{"id":1962103,"url":"https://alion.io/job/valspec-sr-validation-engineer","title":"Sr. 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":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":".NET","optional":true},{"name":"C#","optional":true}],"status":"live","first_seen_at":"2026-10-06T13:05:05Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-15T09:50:38Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"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 Validation Consultant (CSV)\nLocation: Northern California (Onsite/Hybrid Based on Project Requirements)\nAbout Valspec\nValspec is a leading provider of engineering, validation, and lifecycle services to the life sciences industry. We partner with some of the world's most innovative pharmaceutical and biotechnology companies to deliver projects that improve manufacturing performance, product quality, and patient outcomes. Our consultants work at the forefront of digital manufacturing, automation, validation, and regulatory compliance.\nPosition Summary\nValspec is seeking an experienced Lead Validation Consultant to support a major biopharmaceutical client in Northern California. This role will lead Computer System Validation (CSV) activities for Emerson DeltaV Distributed Control System (DCS) and associated GMP manufacturing and automation platforms.\nThe successful candidate will serve as the technical lead for validation strategy, documentation, execution, and compliance activities while working closely with automation, quality, engineering, and manufacturing teams. This individual will play a key role in ensuring validated systems meet regulatory expectations and support reliable GMP operations.\nResponsibilities\nLead Computer System Validation (CSV) activities for Emerson DeltaV DCS and supporting GMP systems.\nDevelop and execute validation strategies in accordance with FDA, GAMP 5, 21 CFR Part 11, Annex 11, and company quality requirements.\nAuthor, review, and approve validation lifecycle documentation, including:Validation Plans\nValidation Master Plans (VMPs)\nRisk Assessments\nUser Requirements Specifications (URS)\nFunctional Specifications\nTraceability Matrices\nIQ/OQ Protocols\nValidation Summary Reports\n\nPartner with automation and engineering teams to evaluate system designs and ensure compliance throughout the system lifecycle.\nReview vendor documentation, FAT/SAT documentation, testing records, and design deliverables.\nLead validation execution activities and coordinate testing efforts across multiple stakeholders.\nAssess system changes and support change control activities for validated systems.\nSupport data integrity assessments and validation activities associated with electronic records and electronic signatures.\nFacilitate deviation investigations, impact assessments, and remediation activities related to validation deliverables.\nCollaborate with Commissioning & Qualification (C&Q), Quality Assurance, Manufacturing, and Automation teams to ensure integrated project execution.\nTrack validation deliverables, schedules, and project milestones while providing status updates to project leadership.\nMentor junior validation engineers and provide technical leadership during project execution.\nContribute to project planning, resource forecasting, and client-facing discussions regarding validation scope and strategy.\nRequired Qualifications\nBachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline.\n10+ years of Computer System Validation experience within FDA-regulated pharmaceutical, biotechnology, or life sciences environments.\nDemonstrated experience leading validation programs for Emerson DeltaV DCS platforms.\nStrong knowledge of the CSV lifecycle and risk-based validation methodologies.\nExperience supporting GMP manufacturing systems and automation platforms.\nDirect experience authoring and executing validation protocols and test documentation.\nStrong understanding of:GAMP 5\n21 CFR Part 11\nData Integrity principles\nFDA and global regulatory requirements\n\nExperience with deviation management, CAPA, and change control processes.\nAbility to lead cross-functional teams and influence project stakeholders.\nExcellent written, verbal, and client-facing communication skills.\nPreferred Qualifications\nPrevious consulting experience supporting large pharmaceutical or biotechnology clients.\nExperience validating manufacturing automation systems, SCADA platforms, MES systems, historians, and integrated process controls.\nFamiliarity with OSI PI, Syncade, Rockwell, Siemens, Honeywell, or related manufacturing systems.\nExperience supporting large capital projects, facility expansions, or new manufacturing sites.\nProven ability to lead multiple validation workstreams simultaneously.\nKey Competencies\nTechnical Leadership\nComputer System Validation (CSV)\nEmerson DeltaV Expertise\nRisk-Based Validation\nRegulatory Compliance\nClient Relationship Management\nStrategic Problem Solving\nCross-Functional Collaboration\nWhy Join Valspec?\nAt Valspec, you'll work alongside industry experts delivering high-impact projects for leading life sciences organizations. We offer challenging technical work, a collaborative culture, and opportunities to influence critical manufacturing and quality initiatives that help bring life-changing therapies to patients.\nJoin a great team supporting world-class life sciences clients throughout Northern California. Apply today!\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":7359,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Testing, Inspection & Certification","Scientific & Lab Software"],"lifecycle":[{"event":"open","at":"2026-10-06T15:58:43Z"}],"visa":[],"liveness":{"score":82,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.822,"p_room":1,"age_days":8,"expected_fill_days":38,"reasons":["conf:0","win:early"],"computed_at":"2026-10-15T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/valspec-sr-validation-engineer","json_url":"https://alion.io/job/valspec-sr-validation-engineer.json","meta":{"generated_at":"2026-10-15T10:29:02Z","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":15830,"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-sr-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-sr-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-sr-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-sr-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fvalspec-sr-validation-engineer"}]}