{"id":3853535,"url":"https://alion.io/job/planet-pharma-validation-engineer-2","title":"Validation Engineer 2","company":{"id":4467183,"name":"Planet Pharma","domain":"planet-pharma.com","url":"https://alion.io/company/planet-pharma","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"B","score":80,"open_postings":11,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-11-08T05:47:12Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bend, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-08-18T00:00:00Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-08T17:00:31Z","board_verified":true,"closed_at":null,"days_open":82,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":82},"description":"Position Summary:\nSeeking a contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with both the Instrumentation and CQV teams.\nThe successful candidate will split time supporting Dawn Bosco’s CQV priorities and the Instrumentation team’s CSV activities. This individual must be comfortable managing multiple priorities simultaneously, producing high-quality documentation, and working hands-on with laboratory instruments and equipment in a regulated cGMP environment. Because the position supports physical equipment and instrument qualification activities, onsite presence in Bend, Oregon is required.\nKey Responsibilities\nDevelop, execute, review, and maintain validation lifecycle documentation, including:\nRisk Assessments\nUser Requirement Specifications (URS)\nDesign Specifications\nTraceability Matrices\nTest Scripts\nValidation Protocols\nDiscrepancies and Deviations\nSummary Reports\nPeriodic Review Documentation\nSystem Retirement Documentation\nSupport qualification and validation activities for new and existing analytical laboratory instruments, computerized systems, and GMP equipment.\nExecute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.\nEnsure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and Annex 11 requirements.\nPartner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation activities.\nPrepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols related to GMP equipment, analytical instruments, and computerized systems.\nUtilize and support the Kneat validation platform, including document creation, workflow routing, approvals, and record closure.\nAssist with Kneat template development and continuous improvement initiatives.\nMaintain inspection-ready documentation in accordance with SOPs, GxP requirements, and site procedures.\nMonitor field execution activities, identify gaps early, drive discrepancy resolution, and escalate issues as appropriate.\nSplit support between the Instrumentation team for CSV activities and the CQV group for qualification execution, documentation updates, and readiness activities.\nTravel between Bend campus buildings as needed to support laboratory instrument and equipment qualification activities.\nPerform other duties as assigned.\nRequired Qualifications\nEducation: Bachelor’s Degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.\nExperience\nMinimum 3-5 years of CQV and/or CSV experience within pharmaceutical, biotechnology, or other regulated industries.\nExperience supporting analytical laboratory instruments and equipment qualification.\nExperience working in cGMP-regulated environments.\nExperience with computerized systems validation and equipment qualification.\nExperience managing multiple validation projects and competing priorities.\nPrevious backlog remediation or high-volume validation support experience is highly desirable.\nTechnical Knowledge\nProven experience using Kneat validation/documentation software.\nStrong understanding of GMP documentation requirements and validation practices.\nKnowledge of:\nGxP regulations\n21 CFR Part 11\n21 CFR Parts 210 and 211\nEU Annex 11\nAnnex 15\nUSP and ASTM standards\nUnderstanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.\nStrong understanding of equipment qualification versus instrument validation requirements.\nKey Competencies\nExcellent technical writing and documentation skills.\nStrong organization and attention to detail.\nAbility to prioritize effectively across multiple projects and stakeholders.\nProactive problem-solving skills.\nAbility to work both independently and collaboratively in a regulated environment.\nStrong communication and cross-functional collaboration skills.\nCommitment to quality, compliance, and data integrity.\nPhysical & Environmental Requirements\nWork within a clean, secure, and regulated GMP environment.\nWear required PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.\nOccasional lifting of up to 50 pounds.\nTravel between site buildings as needed.\nFlexible schedule to support project activities.\nPay ranges between 85-93/hr based on experience","description_format":"text","description_chars":4661,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Flexible schedule"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-11-06T05:00:54Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":3,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 2","filings_12m":2,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":227500,"route":null,"cap_exempt":false,"checked_at":"2026-11-08T10:45:15+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","Alion: sponsorship offered in the employer's own job adverts (24 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