{"schemaVersion":"jobsearcher.job.v1","id":"2943165dc0a5b043a1571d8a","url":"https://jobsearcher.com/jobs/2943165dc0a5b043a1571d8a","canonicalUrl":"https://jobsearcher.com/jobs/2943165dc0a5b043a1571d8a","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.\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.\nProcess Engineer — Upstream / Downstream / Clean Utilities (Consultant) — Contract\nEngagement: Valspec consultant placed onsite at a major biopharmaceutical manufacturing site in the Raleigh-Durham, NC area\nLocation: Raleigh-Durham, NC (onsite)\nType: Contract / consulting — initial term approximately 12 months, with a possibility of extension\nStart: ASAP\nAbout the Engagement\nValspec is seeking Process Engineers to support large-scale biologics drug substance manufacturing at a major biopharmaceutical site in the Raleigh-Durham area. We're looking for candidates who can step into an active, fast-moving environment and contribute with minimal ramp-up. Openings across Upstream, Downstream, and Clean Utilities — candidates with a strength in one area are encouraged to apply.\nRole Overview\nThe Process Engineer will provide engineering support to production and startup activities across Drug Substance manufacturing, with a primary focus in one of the following areas depending on team assignment: Upstream (cell culture/bioreactors), Downstream (purification/chromatography), or Clean Utilities (WFI, clean steam, process gases, and supporting utility systems). This person will partner closely with Manufacturing, Manufacturing Sciences (MSAT), Automation, and Quality to troubleshoot process issues and support equipment and process reliability.\nKey Responsibilities\nProvide engineering technical support for assigned process area, specifying equipment and process gaps within existing facility design.\nTroubleshoot production and startup issues, partnering with Manufacturing and Maintenance to minimize downtime and support equipment reliability.\nSupport process monitoring and control activities within the assigned functional area, ensuring compliance with cGMP requirements.\nAuthor and review technical documentation, including SOPs, protocols, deviations, and change controls, within GMP quality systems.\nSupport process characterization, technology transfer, and continuous improvement initiatives.\nRequired Qualifications\nBS in Chemical, Biochemical, Mechanical, or Biomedical Engineering, or a related technical field.\n5+ years of process or manufacturing engineering experience in a pharmaceutical or biotech GMP manufacturing environment.\nHands-on experience in at least one of: Upstream (cell culture/bioreactor) operations, Downstream (purification) operations, or Clean Utilities systems.\nWorking knowledge of cGMP requirements in a regulated biologics manufacturing environment.\nAble to work onsite in the Raleigh-Durham, NC area and be fully productive quickly given the engagement timeline.\nPreferred Qualifications\nLarge-scale biologics drug substance experience (mammalian cell culture and downstream purification).\nExperience supporting a startup, commissioning, or new-facility environment.\nFamiliarity with relevant unit operations depending on focus area: bioreactors and cell culture systems (Upstream); chromatography, UF/DF, and viral filtration (Downstream); or WFI, clean steam, and process gas systems (Clean Utilities).\nJoin Us\nSalary Range: $70 - $80 / hourly range is an estimate of pay for project-based employment. Range varies based on knowledge, experience, and area of focus. Higher rates possible for short-term assignments and independent contractors. Apply now to be part of a dynamic team driving innovation in North Carolina and beyond.\nWhy Join Valspec?\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:\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.\nJoin a team where your contributions matter, your development is prioritized, and your success is shared.\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.\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.\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.\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":"San Marcos","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-08-05T15:44:26.082Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"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.\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.\nProcess Engineer — Upstream / Downstream / Clean Utilities (Consultant) — Contract\nEngagement: Valspec consultant placed onsite at a major biopharmaceutical manufacturing site in the Raleigh-Durham, NC area\nLocation: Raleigh-Durham, NC (onsite)\nType: Contract / consulting — initial term approximately 12 months, with a possibility of extension\nStart: ASAP\nAbout the Engagement\nValspec is seeking Process Engineers to support large-scale biologics drug substance manufacturing at a major biopharmaceutical site in the Raleigh-Durham area. We're looking for candidates who can step into an active, fast-moving environment and contribute with minimal ramp-up. Openings across Upstream, Downstream, and Clean Utilities — candidates with a strength in one area are encouraged to apply.\nRole Overview\nThe Process Engineer will provide engineering support to production and startup activities across Drug Substance manufacturing, with a primary focus in one of the following areas depending on team assignment: Upstream (cell culture/bioreactors), Downstream (purification/chromatography), or Clean Utilities (WFI, clean steam, process gases, and supporting utility systems). This person will partner closely with Manufacturing, Manufacturing Sciences (MSAT), Automation, and Quality to troubleshoot process issues and support equipment and process reliability.\nKey Responsibilities\nProvide engineering technical support for assigned process area, specifying equipment and process gaps within existing facility design.\nTroubleshoot production and startup issues, partnering with Manufacturing and Maintenance to minimize downtime and support equipment reliability.\nSupport process monitoring and control activities within the assigned functional area, ensuring compliance with cGMP requirements.\nAuthor and review technical documentation, including SOPs, protocols, deviations, and change controls, within GMP quality systems.\nSupport process characterization, technology transfer, and continuous improvement initiatives.\nRequired Qualifications\nBS in Chemical, Biochemical, Mechanical, or Biomedical Engineering, or a related technical field.\n5+ years of process or manufacturing engineering experience in a pharmaceutical or biotech GMP manufacturing environment.\nHands-on experience in at least one of: Upstream (cell culture/bioreactor) operations, Downstream (purification) operations, or Clean Utilities systems.\nWorking knowledge of cGMP requirements in a regulated biologics manufacturing environment.\nAble to work onsite in the Raleigh-Durham, NC area and be fully productive quickly given the engagement timeline.\nPreferred Qualifications\nLarge-scale biologics drug substance experience (mammalian cell culture and downstream purification).\nExperience supporting a startup, commissioning, or new-facility environment.\nFamiliarity with relevant unit operations depending on focus area: bioreactors and cell culture systems (Upstream); chromatography, UF/DF, and viral filtration (Downstream); or WFI, clean steam, and process gas systems (Clean Utilities).\nJoin Us\nSalary Range: $70 - $80 / hourly range is an estimate of pay for project-based employment. Range varies based on knowledge, experience, and area of focus. Higher rates possible for short-term assignments and independent contractors. Apply now to be part of a dynamic team driving innovation in North Carolina and beyond.\nWhy Join Valspec?\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:\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.\nJoin a team where your contributions matter, your development is prioritized, and your success is shared.\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.\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.\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.\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":"2026-08-05T15:44:26.082Z","dateModified":"2026-08-05T15:44:26.082Z","hiringOrganization":{"@type":"Organization","name":"Valspec","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"San Marcos","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"2943165dc0a5b043a1571d8a"},"url":"https://jobsearcher.com/jobs/2943165dc0a5b043a1571d8a"}}