{"schemaVersion":"jobsearcher.job.v1","id":"f1a742c3b5896af89898a843","url":"https://jobsearcher.com/jobs/f1a742c3b5896af89898a843","canonicalUrl":"https://jobsearcher.com/jobs/f1a742c3b5896af89898a843","title":"Process Validation Engineer","description":"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.\n\nValspec'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.\n\nProcess Engineer (Process Validation / PPQ Readiness)\n\nLocation: Sanford, NC (Onsite)\nType: Contract | Full-Time (40 Hours/Week)\nDuration: Approximately 9 Months\n\nPosition Summary\n\nOur client is seeking an experienced Process Engineer to support process validation and Process Performance Qualification (PPQ) readiness activities at a biopharmaceutical manufacturing facility in Sanford, NC. This role will focus on validation strategy development, protocol authorship, qualification planning, and cross-functional execution support to ensure successful PPQ implementation and GMP compliance.\n\nThe successful candidate will work closely with Manufacturing, Quality, Engineering, and Validation teams to drive process qualification activities, manage validation studies, and support issue resolution throughout project execution.\n\nResponsibilities\nAssess current process validation activities and identify gaps requiring remediation.\nDevelop process validation strategies, action plans, and implementation roadmaps.\nAuthor validation protocols, reports, and supporting GMP documentation.\nDevelop qualification strategies for:\nSolution mixing operations\nProcess hold studies\nIn-process hold qualifications\nContainer hold studies\nDevelop airflow visualization (AFV) study strategies for Grade A Biological Safety Cabinets.\nCoordinate and track execution of process qualification and validation activities.\nManage scheduling, documentation, and execution support for hold studies and related validation efforts.\nReview Process FMEA outputs and support alignment of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).\nPartner with Manufacturing, Quality, Engineering, and Subject Matter Experts to ensure successful execution of qualification activities.\nParticipate in project meetings and support validation planning, issue management, and readiness efforts.\nRequired Qualifications\nBachelor's degree in Engineering or related technical discipline.\nExperience supporting process validation and PPQ readiness within a biopharmaceutical or pharmaceutical manufacturing environment.\nStrong technical writing experience, including protocol and report authorship.\nExperience coordinating qualification studies and validation execution activities.\nWorking knowledge of:\nGMP regulations and compliance requirements\nProcess validation principles\nRisk assessment methodologies, including FMEA\nStrong organizational, communication, and cross-functional collaboration skills.\nPreferred Qualifications\nExperience supporting biologics manufacturing operations.\nExperience with process hold studies, container hold studies, and mixing qualifications.\nFamiliarity with airflow visualization (AFV) studies within aseptic manufacturing environments.\nExperience working in FDA-regulated manufacturing facilities.\nAdditional Information\nPrimarily onsite in Sanford, NC.\nLimited remote work may be considered with prior approval.\nFull-time contract position (40 hours per week).\nEstimated duration: approximately nine (9) months.\n\nWhy Join Valspec?\n\nAt 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:\n\nPremium medical coverage\n401(k) with company match\nTuition reimbursement\nUnique performance incentives\nAnd more — all designed to support your growth, well-being, and future.\n\nJoin a team where your contributions matter, your development is prioritized, and your success is shared.\n\nWhen 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.\n\nCandidates 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.\n\nAny 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.\n\nValspec 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.","company":"Valspec","rawCompany":"valspec","city":"Durham","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-08-19T18:45:48.018Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Validation Engineer","description":"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.\n\nValspec'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.\n\nProcess Engineer (Process Validation / PPQ Readiness)\n\nLocation: Sanford, NC (Onsite)\nType: Contract | Full-Time (40 Hours/Week)\nDuration: Approximately 9 Months\n\nPosition Summary\n\nOur client is seeking an experienced Process Engineer to support process validation and Process Performance Qualification (PPQ) readiness activities at a biopharmaceutical manufacturing facility in Sanford, NC. This role will focus on validation strategy development, protocol authorship, qualification planning, and cross-functional execution support to ensure successful PPQ implementation and GMP compliance.\n\nThe successful candidate will work closely with Manufacturing, Quality, Engineering, and Validation teams to drive process qualification activities, manage validation studies, and support issue resolution throughout project execution.\n\nResponsibilities\nAssess current process validation activities and identify gaps requiring remediation.\nDevelop process validation strategies, action plans, and implementation roadmaps.\nAuthor validation protocols, reports, and supporting GMP documentation.\nDevelop qualification strategies for:\nSolution mixing operations\nProcess hold studies\nIn-process hold qualifications\nContainer hold studies\nDevelop airflow visualization (AFV) study strategies for Grade A Biological Safety Cabinets.\nCoordinate and track execution of process qualification and validation activities.\nManage scheduling, documentation, and execution support for hold studies and related validation efforts.\nReview Process FMEA outputs and support alignment of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).\nPartner with Manufacturing, Quality, Engineering, and Subject Matter Experts to ensure successful execution of qualification activities.\nParticipate in project meetings and support validation planning, issue management, and readiness efforts.\nRequired Qualifications\nBachelor's degree in Engineering or related technical discipline.\nExperience supporting process validation and PPQ readiness within a biopharmaceutical or pharmaceutical manufacturing environment.\nStrong technical writing experience, including protocol and report authorship.\nExperience coordinating qualification studies and validation execution activities.\nWorking knowledge of:\nGMP regulations and compliance requirements\nProcess validation principles\nRisk assessment methodologies, including FMEA\nStrong organizational, communication, and cross-functional collaboration skills.\nPreferred Qualifications\nExperience supporting biologics manufacturing operations.\nExperience with process hold studies, container hold studies, and mixing qualifications.\nFamiliarity with airflow visualization (AFV) studies within aseptic manufacturing environments.\nExperience working in FDA-regulated manufacturing facilities.\nAdditional Information\nPrimarily onsite in Sanford, NC.\nLimited remote work may be considered with prior approval.\nFull-time contract position (40 hours per week).\nEstimated duration: approximately nine (9) months.\n\nWhy Join Valspec?\n\nAt 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:\n\nPremium medical coverage\n401(k) with company match\nTuition reimbursement\nUnique performance incentives\nAnd more — all designed to support your growth, well-being, and future.\n\nJoin a team where your contributions matter, your development is prioritized, and your success is shared.\n\nWhen 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.\n\nCandidates 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.\n\nAny 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.\n\nValspec 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.","datePosted":"2026-08-19T18:45:48.018Z","dateModified":"2026-08-19T18:45:48.018Z","hiringOrganization":{"@type":"Organization","name":"Valspec","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Durham","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f1a742c3b5896af89898a843"},"url":"https://jobsearcher.com/jobs/f1a742c3b5896af89898a843"}}