{"id":1924279,"url":"https://alion.io/job/valspec-process-validation-engineer","title":"Process Validation Engineer","company":{"id":688108,"name":"Valspec","domain":"valspec.com","url":"https://alion.io/company/valspec","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":75,"max":85,"currency":"USD","period":"hour","gross":null,"usd_annual":170000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":".NET","optional":true},{"name":"C#","optional":true}],"status":"live","first_seen_at":"2026-10-05T18:31:15Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-15T09:50:38Z","board_verified":true,"closed_at":null,"days_open":9,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":9},"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.\nSenior Process Validation Engineer (Consultant) - Contract\nEngagement: Valspec consultant placed onsite at a biotech manufacturing site in Northern California.\nLocation: Northern CA (onsite)\nType: Contract / consulting - initial term approximately 6-7 months, with a strong likelihood of extension \nStart: ASAP\nAbout the Engagement\nValspec is seeking a Senior Process Validation Engineer to support large-scale biologics drug substance manufacturing at a major biotech site in Northern California. This is a consulting engagement supporting an active validation effort, so we need a senior-level candidate who can hit the ground running - owning validation deliverables independently in a GMP environment with minimal ramp-up.\nWhy this engagement stands out:\nHigh-visibility validation work at a major biotech site.\nInitial 6-7 month term with a strong likelihood of extension (not guaranteed, but the work pipeline points that way).\nRole Overview\nThe Senior Process Validation Engineer will independently author and execute process validation deliverables across the validation lifecycle, partnering closely with Manufacturing Sciences (MSAT), Manufacturing, Quality, and Process Development. As a senior individual contributor, this person is expected to own deliverables with minimal oversight and drive cross-functional alignment. The role centers on Process Performance Qualification (PPQ) and Continued Process Verification (CPV) for commercial drug substance processes, with an emphasis on right-first-time documentation and on-time execution.\nKey Responsibilities\nAuthor, execute, and report on PPQ protocols for drug substance manufacturing processes.\nSupport the full process validation lifecycle - Stage 1 (process design) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification).\nDevelop and maintain control strategy elements, process monitoring plans, and CPV trending.\nPerform statistical analysis of process data (capability, trending, limits) using Minitab or JMP.\nAuthor and review validation deviations, investigations, CAPAs, and change controls within GMP quality systems.\nPartner cross-functionally with MSAT/Manufacturing Sciences, Manufacturing, QA, and Process Development to align validation activities with production schedules.\nSupport process characterization and tech-transfer activities as needed.\nEnsure all work complies with FDA process validation guidance, ICH Q8-Q12, and EU GMP (Annex 15).\nMaintain accurate, audit-ready GMP documentation and validation records.\nRequired Qualifications\nBS in Chemical, Biochemical, or Biomedical Engineering, Biology, Biochemistry, or a related technical field.\n8+ years of process validation experience in a pharmaceutical or biotech GMP manufacturing environment, at a senior/lead level. \nHands-on experience authoring and executing PPQ protocols and reports.\nWorking knowledge of the process validation lifecycle and current FDA process validation guidance.\nStatistical analysis experience using Minitab or JMP.\nStrong GMP technical writing skills.\nAble to work onsite in Northern California and be fully productive from day one given the short engagement window.\nPreferred Qualifications\nLarge-scale biologics drug substance experience (mammalian cell culture and downstream purification).\nPrior experience at a large-scale commercial biologics manufacturer.\nFamiliarity with relevant unit operations: bioreactors, chromatography, UF/DF, viral filtration.\nExperience with electronic batch records / MES and validation lifecycle management systems.\nTech-transfer experience.\nWhat Makes a Strong Fit for This Engagement\nBecause this is a focused, senior-level engagement, the ideal candidate is a career consultant or contractor who has owned PPQ campaigns end-to-end and can be fully productive almost immediately - there isn't runway for a long ramp. Prior large-scale biologics drug substance experience and recent contract history are strong positive signals. Local or relocation-ready candidates are preferred given the onsite requirement in Northern California.\nJoin Us\nSalary Range: $75 - $85 / hourly range is an estimate of pay for project-based employment. Range varies based on knowledge and experience. Higher rates possible for short-term assignments and independent contractors. If you are a dedicated Process Engineer with a passion for ensuring the quality and compliance of manufacturing processes in the biopharmaceutical industry, we want to hear from you! Join us on our mission to revolutionize medicine and transform lives. Apply now to be part of a dynamic team driving innovation in California 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.","description_format":"text","description_chars":7005,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":true,"industries":["CRO & CDMO Services","Testing, Inspection & Certification","Scientific & Lab Software"],"lifecycle":[{"event":"open","at":"2026-10-05T19:16:37Z"}],"visa":[],"liveness":{"score":82,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.822,"p_room":1,"age_days":9,"expected_fill_days":38,"reasons":["conf:0","win:early"],"computed_at":"2026-10-15T05:46:00Z"},"pay":{"stated_usd_annual":170000,"is_top_pay":true},"html_url":"https://alion.io/job/valspec-process-validation-engineer","json_url":"https://alion.io/job/valspec-process-validation-engineer.json","meta":{"generated_at":"2026-10-15T12:10:34Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":18678,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-16T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":688108},"rest":"https://alion.io/mcp/rest/get_company?id=688108"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fvalspec-process-validation-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fvalspec-process-validation-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fvalspec-process-validation-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/valspec-process-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fvalspec-process-validation-engineer"}]}