{"id":3073633,"url":"https://alion.io/job/ambiopharm-qa-validation-engineer","title":"QA Validation Engineer","company":{"id":2185248,"name":"AmbioPharm","domain":"ambiopharm.com","url":"https://alion.io/company/ambiopharm","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paycor","truth_index":null},"role":"QA","role_family":"QA","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["North Augusta, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":85000,"max_usd":167000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":587},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-22T10:07:25Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-24T00:57:41Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"QA Validation Engineer\nThis role is onsite at our North Augusta, South Carolina location. Relocation is required, please apply to learn more about our relocation assistance program.\nPurpose and scope of the position:\nThe Quality Assurance Validation Engineer is responsible for providing independent Quality Assurance oversight, review, and approval of qualification and validation activities to ensure compliance with applicable cGMP, regulatory, and company requirements. This position serves as the quality representative for validation programs associated with manufacturing processes, equipment, utilities, cleaning processes, analytical test methods, and related systems. The QA Validation Engineer collaborates with cross-functional teams including Manufacturing, Engineering, Validation, Facilities, Metrology, Quality Control, and Technical Services to assess validation strategies, review technical documentation, evaluate deviations and change controls, and ensure that validation activities are scientifically sound, properly documented, and suitable to support the manufacture and testing of pharmaceutical active ingredients. The role is responsible for maintaining validation compliance throughout the lifecycle of qualified systems and validated processes while promoting quality culture, data integrity, continuous improvement, and inspection readiness across the organization.\nPrimary accountabilities:\nPerform Quality Assurance review and approval of validation lifecycle documentation, including Validation Master Plans (VMPs), risk assessments, protocols, reports, and periodic reviews.\nReview and approve equipment qualification documentation, including User Requirements Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).\nReview and approve utility qualification activities and supporting documentation for systems used in manufacturing and laboratory operations, including water systems, HVAC, and other GMP utilities.\nReview and approve process validation protocols and reports for commercial API manufacturing processes.\nReview and approve cleaning verification/validation protocols, reports, and associated risk assessments.\nEnsure validation activities comply with applicable FDA, ICH, USP, EU GMP, and regulatory requirements.\nReview and approve calibration, preventive maintenance, and qualification activities performed by internal departments and external service providers.\nAssess the quality and completeness of validation data packages and verify that acceptance criteria are scientifically justified and adequately supported.\nParticipate in commissioning and qualification activities associated with new equipment, facilities, process improvements, and capital projects.\nEvaluate proposed changes through the Change Control system to determine qualification and validation impact.\nReview and approve deviations, investigations, CAPAs, and change controls associated with validation and qualification activities.\nWork cross-functionally with Manufacturing, Engineering/Facilities, Metrology, Validation,[DR2.1][TC2.2] Quality Control, and Technical Services to resolve validation-related compliance issues.\nSupport internal audits, customer audits, and regulatory inspections related to validation programs.\nAssist in the development, revision, and continuous improvement of validation and quality system SOPs.\nPerform additional duties as assigned by Quality Management.\nLeadership and Behaviour:\nDemonstrates integrity, accountability, and an independent quality mindset while consistently promoting cGMP compliance, data integrity, and patient-focused decision making.\nCollaborates effectively across departments to drive quality outcomes, resolve issues, and support timely execution of validation, qualification, and quality system activities.\nExercises sound judgment, critical thinking, pragmatic and a risk-based approach when evaluating technical and compliance-related challenges.\nLeads by example through professionalism, continuous improvement, knowledge sharing, and a commitment to operational excellence and inspection readiness.\nPromote a culture of quality, data integrity, compliance, safety, and continuous improvement throughout the organization.\nQualifications:\nRequired\nBachelor's degree in Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline.\nMinimum of 5 years of experience in Quality Assurance, Validation, Engineering, Quality Control, or Manufacturing within the pharmaceutical, biotechnology, or related regulated industry.\nStrong knowledge of cGMP regulations, including FDA 21 CFR Parts 210/211, applicable data integrity requirements, USP, and ICH guidance.\nExperience reviewing and approving qualification, validation, and lifecycle management documentation.\nExperience with process validation, equipment qualification, cleaning validation, and analytical method validation activities.\nUnderstanding of risk management principles and validation lifecycle concepts.\nExcellent technical writing, document review, and data evaluation skills.\nStrong organizational skills with the ability to manage multiple priorities.\nEffective verbal and written communication skills.\nProficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.\nPreferred\n7+ years of GMP pharmaceutical or biotechnology industry experience.\nExperience with API manufacturing operations.\nFamiliarity with computerized system validation (CSV) and data integrity assessments.\nExperience with chromatographic laboratory systems and Empower software.\nPrevious participation in FDA, customer, or international regulatory inspections.\nASQ Certified Quality Engineer (CQE), Certified Pharmaceutical GMP Professional (CPGP), or similar certification.\nADA Requirements\nMust be able to push, pull, squat, stand, and walk throughout the workday with or without reasonable accommodation.\nMust be able to lift up to 20 lbs.\nMust be able to wear required personal protective equipment, including safety glasses and safety shoes, while in designated areas.\nMust be medically qualified to wear a respirator when required for assigned duties.\nMust be able to work in a chemical manufacturing environment.","description_format":"text","description_chars":6302,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Relocation assistance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Biotechnology","Health Care","Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-22T10:07:25Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring 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