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Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. Automation QA Engineer Location: Remote Employment Type: Contract / Consulting (6-12+ months) Start Date: ASAP About the Role: We are seeking experienced Automation QA Engineers to support our clients in North Carolina. These roles will support automation quality assurance activities within a GMP-regulated pharmaceutical manufacturing environment, with a strong focus on commissioning, qualification, validation, and lifecycle documentation for automation systems. This is an excellent opportunity for candidates with pharmaceutical or biotech automation QA experience who are comfortable working cross-functionally with Validation, Engineering, Manufacturing, and Quality teams in support of large-scale capital and operational projects. Key Responsibilities Provide QA oversight and support for automation-related qualification and validation activities Review and approve validation lifecycle documentation including: IQ/OQ/PQ protocols and reports Risk assessments Traceability matrices Change controls Deviations and CAPAs Support automation systems operating within GMP manufacturing environments Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 requirements Partner with Automation, CQV, CSV, Manufacturing, and Quality teams to ensure compliant execution of project deliverables Participate in document reviews, project meetings, and quality assessments Support audit readiness and inspection preparedness activities Assist with implementation and continuous improvement of validation and QA processes Preferred Systems / Technologies Experience with one or more of the following is highly preferred: DeltaV Rockwell / PLC systems SCADA or HMI platforms MES systems (Syncade experience is a plus) Historian systems Automated manufacturing equipment within pharma/biotech environments Qualifications Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field preferred 3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or regulated manufacturing industry Strong understanding of GMP compliance and validation lifecycle principles Experience reviewing and approving GMP documentation Familiarity with data integrity and 21 CFR Part 11 requirements Excellent communication and cross-functional collaboration skills Ability to work independently in a remote environment Why Join Valspec? At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including: Premium medical coverage 401(k) with company match Tuition reimbursement Unique performance incentives And more — all designed to support your growth, well-being, and future. Join a team where your contributions matter, your development is prioritized, and your success is shared. When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored. Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time. Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
Valpro has several available opportunities supporting our world-class client sites or partner organizations. Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below. Automation QA Engineer Location: Remote Employment Type: Contract / Consulting (6-12+ months) Start Date: ASAP About the Role: We are seeking experienced Automation QA Engineers to support our clients in North Carolina. These roles will support automation quality assurance activities within a GMP-regulated pharmaceutical manufacturing environment, with a strong focus on commissioning, qualification, validation, and lifecycle documentation for automation systems. This is an excellent opportunity for candidates with pharmaceutical or biotech automation QA experience who are comfortable working cross-functionally with Validation, Engineering, Manufacturing, and Quality teams in support of large-scale capital and operational projects. Key Responsibilities Provide QA oversight and support for automation-related qualification and validation activities Review and approve validation lifecycle documentation including: IQ/OQ/PQ protocols and reports Risk assessments Traceability matrices Change controls Deviations and CAPAs Support automation systems operating within GMP manufacturing environments Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 requirements Partner with Automation, CQV, CSV, Manufacturing, and Quality teams to ensure compliant execution of project deliverables Participate in document reviews, project meetings, and quality assessments Support audit readiness and inspection preparedness activities Assist with implementation and continuous improvement of validation and QA processes Preferred Systems / Technologies Experience with one or more of the following is highly preferred: DeltaV Rockwell / PLC systems SCADA or HMI platforms MES systems (Syncade experience is a plus) Historian systems Automated manufacturing equipment within pharma/biotech environments Qualifications Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field preferred 3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or regulated manufacturing industry Strong understanding of GMP compliance and validation lifecycle principles Experience reviewing and approving GMP documentation Familiarity with data integrity and 21 CFR Part 11 requirements Excellent communication and cross-functional collaboration skills Ability to work independently in a remote environment Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives. When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored. Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time. Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
HME has been creating innovative products for the drive-thru and pro-audio industries since 1971. From the very beginning, we've known these solutions would never have happened without the customer-focused people who make up our company. HME has a team environment with a culture of collaboration, learning, and growth. With subsidiaries located in California, Missouri, Canada, UK, India, and China, companies around the world depend on HME for clear, reliable communication solutions. From setting the standard for drive-thru headsets and timer systems in the quick service restaurant (QSR) industry to developing professional audio equipment used in the Olympic Games, HME strives to create the newest, most innovative products on the market while providing quality care and attention to its customers. At HME you will have the opportunity to learn and grow while developing our future products. Come join our team! HME is looking for your talent! We are hiring for a temporary 6-month Quality Technician I. The Quality Technician I will work closely with the Supplier and Product Quality Engineering teams to support and improve the quality of our products and operations. Identifies and troubleshoots processes, material, or equipment problems to minimize down time and recommend solutions to restore process flow. Promotes, supports, and implements Lean Manufacturing and Continuous Improvement activities in Manufacturing. What you will do in the position: Create and update ballooned drawings to facilitate incoming quality inspections. Support housekeeping, organization, and maintenance of QA lab. Conduct tests as instructed by quality engineering. Request and manage material quarantines, including inspections, inventory transactions, dispositioning and reporting of findings. Support evaluation and processing of Special Build Requests and other activities needed to assess part changes or deviations. Create inspection and rework instructions as needed. Set up and support quality inspection test stations as requested and through regular preventative maintenance. Create corrective action tickets and follow up with owners to ensure quick and effective resolution. Support nonconformance investigations. Disposition materials that are segregated by production as defective. Update tickets and dispositions. Escalate the need for supplier corrective actions to supplier quality engineering. Coordinate customer returns analysis through functional verification testing and follow-up with repair technicians and engineers. Assist in managing QA inventory locations through material transfers and audits. What you will need to succeed: Working knowledge of electromechanical product manufacturing, test, and quality processes. Strong organizational and communication skills. Ability to interpret basic electro-mechanical part and assembly drawings. Proficient in basic application of test methodologies, procedures and techniques. Understanding of ERP (Enterprise Resource Planning) systems for transacting/moving materials. Demonstrate an understanding of basic quality terms, definitions and concepts. Demonstrate the ability to apply ASQ 7 quality tools (Pareto, Fishbone, Flowchart, Control Chart, Check Sheet, Scatter diagrams, and Histograms). Understanding of MS Office applications required. Experience 2+ years Education License/Certification - Preferred Travel: 0% The posted pay range, $20.44 - $27.22/hour, is what we reasonably expect to pay for the role. This may vary depending on experience and other factors. The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee will occasionally lift and move up to 10 pounds, 50 pounds with assistance.
*Production Assembler* Baja Designs/sPOD is located in San Marcos, CA and is well known for revolutionizing the off-road industry with leading lights along with precise power distribution systems. Performance lighting solutions from Baja Designs have been at the forefront of off-road lighting for 30+ years. We specialize in LED light bars, LED auxiliary lights, the world’s first laser and auxiliary lights. In addition, our sPOD precision power distribution systems are created with top-tier 12V power control solutions for various applications, including camper vans, race trucks, industrial equipment, and agriculture. We have a solution for every rider, driver, and adventurist including ATV, Motorcycle, Adventure Bike, agricultural, marine and heavy equipment. Off-road enthusiasts are encouraged to apply! *Why Work with Us?* The 6 Core Values at Baja Designs: _*Respect*__- Everyone is a priority_ _*Accountability*__- Regardless of title, we are all responsible for our performance, words, and actions_ _*Personal + Professional Growth- *__Support each other’s individual growth so we grow as a team_ _*Teamwork- *__We contribute & collaborate in a positive manner_ _*Clear + Honest Communication- *__Our effective communication leads to our success_ _*Work/Life Balance- *__We work to live, not live to work_ *Baja Designs Mission Statement* _“We Manufacture industry-leading solutions that inspire off road and automotive enthusiasts alike to explore the unknown. We stay on the cutting edge through best-in-class performance, craftmanship, consumer engagement, and providing meaningful solutions.”_ Baja Designs is proud to be an equal opportunity employer. Baja Designs recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. *What you can look forward to as a Baja Designs employee: * We offer competitive pay and a comprehensive benefits package including health insurance; employer paid dental, vision, disability, life, and AD&D; 401K with a generous company match; tuition assistance; holiday, vacation and paid sick time; casual work environment, and much more! *If the description above strikes an interest to you, keep on reading for more!* *What the Production Assembler* *will do: * * Perform any assembly-type functions using hand and power tools * Ability to work in a fast-paced environment with a focus on zero defect manufacturing * Assemble work orders in the same day/ 24-hour turnaround time * Inspect finished products to ensure it conforms to customer requirements * Package boxes using specified packing materials for Vehicle Specific Kits (VSK) * Packaging finished products and correctly labeling * Producing high quality items according to order specifications and production procedures * Interpreting technical documents, such as diagrams, schematics, blueprints, or other verbal or written instructions. * Audit BOM and Build sheets daily * Meet production time frames and quality objectives set by the company * Physical requirements may include lifting and moving boxes * Keeping a clean and tidy workspace. * Meeting all safety requirements of the company and industry. Marginal Duties: * Assist in any other areas within the Warehouse as needed. This includes Production and Warehouse duties. *What You Bring to the Team* * 2+ years of Production experience or related field * Manufacturing experience * Computer expertise navigating ERP system; NetSuite Oracle *What’s next?* If you fit the qualifications, we’re looking for in this opportunity, you’ll be contacted to schedule a phone interview to further discuss your expectations and goals you have! *To learn more about us, please visit our website at *_bajadesigns.com. _ _Visit bajadesigns.com/careers/ to access the California Applicant Privacy Policy_ _This organization participates in E-Verify._ Follow us on *Facebook, Twitter, Instagram, LinkedIn* for updates happening at Baja Designs! Pay: $18.00 - $20.00 per hour Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Employee discount * Health insurance * Health savings account * Life insurance * Paid time off * Tuition reimbursement * Vision insurance Work Location: In person
Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About the role: Primary focus is to build product by following processes and instructions to meet validation and build goals. Work Mode At Boston Scientific, we value collaboration and synergy. This role follows a onsite work model, requiring employees to be in our local office five days per week. Relocation Relocation assistance is not available for this position at this time. VISA Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time. Your responsibilities will include: Assemble, repair, inspect and/or test products following instructions. Ability to read and comprehend basic instructions and other work-related documents, written in English. Work with engineers on process modifications and suggest process improvement opportunities. Set up and operate a variety of manufacturing machines or equipment following written instructions in English. Clean tools and equipment per instructions. Record information on approved documents. Dispose hazardous waste material on corresponding hazardous waste areas. Resolve problems and make routine recommendations. Train other employees when necessary. Maintain all certifications required to remain in compliance. Work overtime as required. Sit and/or stand for extended periods of time as needed. Required qualifications: High School Diploma or equivalent 2 years to less than 5 years of work experience in manufacturing and/or assembly Ability to use and adjust a microscope Ability to work with small parts for an extended period of time This position requires proficiency in communication and understanding of English, including reading work instructions to consistently build defect free medical products. Preferred qualifications: Previous medical device experience preferred, but not required. Experience with soldering, hand tools and power tools/drills. Experience working with catheters and in a cleanroom environment. Experience with Lean Manufacturing and related principles and working directly with the engineers to make continuous improvement changes. Experience with maintaining accurate records including training files and shop floor paperwork. Experience training others. Experience working in a pre-production environment. Requisition ID: 629352 Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class. Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Have a passion for coffee? Interested in joining a small, tightly knit staff? Want to increase your knowledge and develop new skills through a proven, rigorous education and training program? How would you like to become a confident and reliable member of a quality-focused operation that invests in its employees? *About us* We are a specialty coffee shop dedicated to our craft, our staff, our customers, our community, and our coffee's origins. We are looking for a part-time Production Associate preferably with prior coffee industry experience. *Hone your craft* * Acquire practical knowledge of each step of coffee production—from receiving green coffee, to maintenance and quality control, to invoicing, packaging, and delivering wholesale orders. * Learn and grow with a well-run and successful operation * Bring your dependability, mindfulness, attention to detail, ability to multitask, and composure under pressure *Be a part of the family* * Promote a safe and respectful environment * Work well independently and communicate comfortably in a team setting * Be you and make a difference * Be recognized for your contribution *Consider the customer experience* * Brighten each customer's day * Provide a smooth experience from ordering to delivery * Competently communicate with online and wholesale customers * Consistently deliver high standards *Job Responsibilities Include, But Are Not Limited To* * Ability to follow processes, policy and procedures of a coffee roasting company * Capable of working as a team-player in a fast-paced production environment * Stock shelves/racks * Bag/seal roasted coffee efficiently * Work off of packing lists and invoices to fulfill customer orders * Sense of urgency/ability to switch gears easily when needed * Ability to lift 50 lbs on a regular basis * Pick/pack customer orders efficiently with the goal of 100% accuracy * Help maintain, clean production/order fulfillment areas at all times * Capable of loading and unloading the company vehicle * Checking deliveries for accuracy * Follow established standard operating procedures Other responsibilities delegated by the Director of Operations as needed. *This position* * Part-time; Monday - Friday * Starting pay at $21/hr * Paid sick leave, paid time off, health insurance, retirement plan, employee discounts * Strong training / education program that will build skills & growth opportunities For more details, check out the key responsibilities for this particular role (www.zumbarcoffee.com/careers/production-associate), potential career opportunities (www.zumbarcoffee.com/careers/our-organization), and learn more about ZUMBAR Coffee & Tea! Want to hear from us sooner? Email us your résumé, why you'd be a good fit for our team, your availability & max/ min hours desired, and tell us what you love about coffee! Job Type: Part-time Pay: From $21.00 per hour Benefits: * Employee discount * Health insurance * Paid time off * Retirement plan Application Question(s): * Why would you be a good fit for our team? * What is your availability? (Daily and weekly. Be specific.) * Desired hours per week Education: * High school or equivalent (Preferred) Language: * English (Required) Shift availability: * Day Shift (Required) Work Location: In person
Position Summary The CNC Machinist is responsible for designing and manufacturing high quality, high precision injection molds and tooling and will play a role in the design, construction and build of injection molds. The CNC Machinist will be responsible for mold design, tooling repair, revisions, mill, lathe and sinker machine programing. Essential Duties & Responsibilities Design tooling for prototype plastic injection molds, as well as fixtures for quality testing; this includes conceptualization, vendor sourcing and collaboration Create CAD and SolidWorks files and drawings for assembly fixtures using 3D Software. Work with engineers and tool designers to design, develop and modify molds. Provide technical expertise for all injection mold tooling. Providing strategic feedback to engineers and give design input for mold performance and implement modifications as corrective actions Build spare parts for existing tooling. Drive collaboration with manufacturing technology, product design, R&D engineering, environmental safety & health, and finance to deliver creative and effective prototype system designs, as well as external vendors supporting the design, construction, and commissioning of prototype molds. Knowledge & Skills Able to fabricate, repair and maintain high precision prototype injection molds Must have training in Mastercam, SolidWorks, CAD/CAM, Esprit software applications. Must know how to use the appropriate precise measuring tools Proficient in creating, reading and understanding of tooling and blueprints. Competent in the use of the following: CNC lathe, CNC mill, 4 axis Wire EDM and Mitsubishi CNC sinker EDM Minimum Qualifications, Education & Experience Must be at least 18 years of age High School diploma, Bachelor’s degree preferred Minimum 6 years of trade or field training Minimum 4 years of experience in close tolerance work Work Environment Work is performed in a tool room environment While performing the duties of this job, the employee may be required to sit or stand for long periods of time, depending on the equipment they are operating Must be able to occasionally move and lift objects of up to 25 lbs. Salary Range - $99,000 - $141,900,000 The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.
Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. CQV Consultant – Upstream / Downstream / CIP / PSE / Clean Utilities Location: Holly Springs (100% Onsite) Type: Long-Term Contract Start Date: ASAP Overview We are seeking experienced CQV Consultants to support a major biopharmaceutical manufacturing project in Holly Springs, NC. This is a long-term onsite opportunity supporting commissioning, qualification, and validation activities across multiple process and utility systems in a GMP manufacturing environment. We are specifically looking for strong "A+" level consultants with hands-on pharmaceutical or biotech project experience supporting large-scale manufacturing operations. We are hiring CQV professionals with experience in one or more of the following areas: Upstream Processing Downstream Processing CIP (Clean-in-Place) Systems PSE (Process Support Equipment) Clean Utilities Key Responsibilities Execute CQV lifecycle activities including commissioning, IQ/OQ, and field verification Support startup and qualification of GMP manufacturing equipment and utility systems Author, review, and execute validation documentation and protocols Coordinate with engineering, operations, quality, automation, and project teams Support deviation investigations, change controls, and CAPA activities Ensure compliance with GMP, FDA, and regulatory requirements Participate in walkdowns, system turnover, and punch-list resolution Maintain accurate documentation in accordance with data integrity and quality standards Qualifications Prior CQV experience in pharmaceutical, biotech, or GMP-regulated manufacturing environments Strong knowledge of commissioning and qualification processes Experience supporting one or more of the following: Upstream, Downstream, CIP, PSE, or Clean Utilities systems Familiarity with GMP documentation practices and regulatory requirements Ability to work onsite in Holly Springs, NC on a full-time basis Strong communication and cross-functional collaboration skills Preferred Experience Large-scale biologics or vaccine manufacturing projects Startup or greenfield facility experience Experience with DeltaV, MES, or automated process systems Knowledge of clean utilities including WFI, clean steam, compressed gases, and purified water systems Why Join Valspec? At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including: Premium medical coverage 401(k) with company match Tuition reimbursement Unique performance incentives And more — all designed to support your growth, well-being, and future. Join a team where your contributions matter, your development is prioritized, and your success is shared. When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored. Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time. Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
Valpro has several available opportunities supporting our world-class client sites or partner organizations. Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below. CQV Consultant – Upstream / Downstream / CIP / PSE / Clean Utilities Location: Holly Springs (100% Onsite) Type: Long-Term Contract Start Date: ASAP Overview We are seeking experienced CQV Consultants to support a major biopharmaceutical manufacturing project in Holly Springs, NC. This is a long-term onsite opportunity supporting commissioning, qualification, and validation activities across multiple process and utility systems in a GMP manufacturing environment. We are specifically looking for strong "A+" level consultants with hands-on pharmaceutical or biotech project experience supporting large-scale manufacturing operations. We are hiring CQV professionals with experience in one or more of the following areas: Upstream Processing Downstream Processing CIP (Clean-in-Place) Systems PSE (Process Support Equipment) Clean Utilities Key Responsibilities Execute CQV lifecycle activities including commissioning, IQ/OQ, and field verification Support startup and qualification of GMP manufacturing equipment and utility systems Author, review, and execute validation documentation and protocols Coordinate with engineering, operations, quality, automation, and project teams Support deviation investigations, change controls, and CAPA activities Ensure compliance with GMP, FDA, and regulatory requirements Participate in walkdowns, system turnover, and punch-list resolution Maintain accurate documentation in accordance with data integrity and quality standards Qualifications Prior CQV experience in pharmaceutical, biotech, or GMP-regulated manufacturing environments Strong knowledge of commissioning and qualification processes Experience supporting one or more of the following: Upstream, Downstream, CIP, PSE, or Clean Utilities systems Familiarity with GMP documentation practices and regulatory requirements Ability to work onsite in Holly Springs, NC on a full-time basis Strong communication and cross-functional collaboration skills Preferred Experience Large-scale biologics or vaccine manufacturing projects Startup or greenfield facility experience Experience with DeltaV, MES, or automated process systems Knowledge of clean utilities including WFI, clean steam, compressed gases, and purified water systems Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives. When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored. Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time. Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Technical Operations Process Engineer. This position independently supports manufacturing operations by applying engineering and scientific principles to improve process performance, resolve issues, and ensure product quality. This role leads routine technical activities and contributes to process development, validation, and continuous improvement initiatives. This position will be onsite in San Diego, CA. The Responsibilities Independently execute process optimization, characterization and validation activities Lead portions of technical transfer projects from R&D to Manufacturing Own investigations for NCs, CAPAs, and deviations of moderate complexity Design and analyze DOE studies; implement data-driven improvements Develop process and material specifications Author and revise technical documentation (SOPs, validation protocols/reports) Execute change plans from feasibility assessment through implementation, ensuring alignment with cross-functional stakeholders and business objectives Support supplier qualification activities and material characterization efforts Contribute to continuous improvement initiatives Ensure compliance with QMS and regulatory requirements Perform other work-related duties as assigned The Individual Required: Bachelor’s degree (BS/BA) in Engineering or related technical field 3–5 years of experience in a cGMP-regulated manufacturing environment or equivalent Strong analytical thinking and structured problem-solving capabilities Experience with process development, optimization, scale-up, and standardization Proficiency in Design of Experiments (DOE), Statistical Process Control (SPC), and data analysis Ability to independently design experiments, interpret data, and make data-driven decisions Experience with process validation (IQ/OQ/PQ) and technical documentation Knowledge of quality systems, cGMP regulations, and compliance requirements Strong project management skills with ability to manage multiple priorities and meet deadlines Effective written and verbal communication skills Ability to work both independently and collaboratively across cross-functional teams Proficiency with standard computer applications (e.g., Microsoft Office, data analysis tools) Ability to troubleshoot and resolve complex technical issues with minimal supervision Strong organizational skills and attention to detail Demonstrated ability to drive continuous improvement initiatives Capable of working in a fast-paced, regulated manufacturing environment This position is not currently eligible for visa sponsorship. Preferred: Six Sigma certification (Green Belt or Black Belt) The Key Working Relationships Internal Partners: Quality Control, Quality Assurance, Manufacturing, R&D, Chemistry, Regulatory, Engineering and Supply Chain External Partners: Suppliers and Customers The Work Environment The work environment characteristics are representative of an office, laboratory and manufacturing environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples The Physical Demands Sitting, standing, walking, lifting, carrying, reaching, pushing, and pulling. Other physical demands include bending, crawling, stooping, vision, grasping, climbing or balancing, kneeling, crouching, talking or hearing. Position may be required to use Personal Protective Equipment as posted. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $89,008.92 - $105,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected] . #LI-HF1