1,483 manufacturing validation engineer jobs at 792 companies in United States
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Validation Engineer II
Houston, Texas, United States
OnsiteFull Time
Empower Pharmacy: Private U.S. 503A compounding pharmacy and FDA-registered 503B outsourcing facility serving patients, providers, and pharmacies.
3+ YOEBS in engineering or scientific field required; 3+ years validation experience in regulated manufacturing preferred; expertise in CQV, equipment/process/computer system validation, cGMP/GAMP/21 CFR Part 11; strong project, analytical, and communication skills.
AI-enabled analytics tools, validation software, quality management systems, Microsoft Office, digital documentation platforms
Principal BioPharma Manufacturing Validation Engineer
Westborough, Massachusetts, United States
$119k-$170k/yrOnsiteFull Time
AstellasTokyo Stock Exchange: 4503: Public Japanese pharmaceutical researching, manufacturing, and selling prescription medicines for patients worldwide.
8+ YOEBS (10+ yrs) or MS (8+ yrs) in engineering or related discipline; extensive GMP biopharma validation experience supporting PPQ, risk-based validation, regulatory filings, data integrity, and mentoring of junior staff.
BWI North America: Private automotive Tier-1 supplier manufacturing brake and suspension systems for vehicle manufacturers worldwide.
Bachelor's degree in engineering, experience in validation/test/quality in manufacturing, ability to develop/execute validation protocols, statistical analysis, report writing, and cross‑functional collaboration.
MATLAB, Minitab, EMC, LabVIEW, Python, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft SharePoint
Voyant Beauty: Private U.S.-based contract manufacturer and supply-chain partner producing personal-care, beauty, and household products for consumer brands.
1+ YOEBachelor's in Mechanical/Chemical Engineering or related; 1-3 years validation experience in cGMP manufacturing preferred; strong IQ/OQ/PQ, SOP writing, cGMP compliance, testing, and validation skills.
Brentwood Industries: Family-owned plastics manufacturer producing thermoformed and injection-molded products for water, medical, cooling-tower, battery, and construction markets.
2+ YOEMinimum 2 years quality/validation engineering in manufacturing (plastics preferred). Bachelor’s in engineering preferred. Hands-on IQ/OQ/PQ experience, ISO 9001 knowledge, Microsoft Office and QMS proficiency, strong communication and auditing skills.
Oxford BiomedicaLondon Stock Exchange: OXB: Public UK cell and gene therapy CDMO developing and manufacturing viral vectors for pharmaceutical and biotechnology clients.
5+ YOEBachelor's in science/engineering,5+ years executing validation in regulated manufacturing,knowledge of FDA expectations,CQV documentation experience,and ability to lead complex validation projects.
RayzeBio: RayzeBio is a clinical-stage radiopharmaceutical therapeutics developing targeted cancer medicines for people with solid tumors.
5+ YOEBS/MS in scientific/engineering discipline or equivalent, 5+ years GMP manufacturing and validation experience (radiopharmaceutical/injectable preferred), strong technical writing, regulatory knowledge, and leadership in validation programs.
RayzeBio: RayzeBio is a clinical-stage radiopharmaceutical therapeutics developing targeted cancer medicines for people with solid tumors.
5+ YOEBS/MS in scientific or engineering discipline or equivalent,5+ years GMP manufacturing and validation experience,strong technical writing,leadership,regulatory validation knowledge,and ability to work in GMP cleanrooms.
Cardinal HealthNYSE: CAH: Global healthcare products and services provider.
2+ YOEBachelor's degree in engineering or related science preferred; 2–4 years of validation experience in cGMP pharmaceutical or biotechnology manufacturing preferred, with regulatory and project management expertise.
User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Standard Operating Procedures (SOPs), Computer System Validation (CSV), Microsoft Excel
Delta ModTech: Family-owned American manufacturer of turnkey web converting, coating, and packaging machinery for regulated industries.
7+ YOEBachelor's degree in engineering,7+ years validation experience with manufacturing equipment or software,experience in regulated environments preferred,leadership and mentorship skills,proficiency with Microsoft Office.
Microsoft Office, Adobe Creative Suite, FrameMaker
Thermo Fisher ScientificNYSE: TMO: The world leader in serving science.
8+ YOE8+ years in pharmaceutical/biotech validation; aseptic processing and media fill experience; sterile manufacturing background; strong technical writing; ability to lead validation projects.
AmgenNASDAQ: AMGN: Developing innovative medicines to fight serious diseases.
2+ YOERequires high school diploma/GED with 8 years, associate's with 6 years, bachelor's with 2 years, or master's degree, plus manufacturing and operations experience. GMP biotechnology, validation, technical writing, and regulatory knowledge preferred.
FagronEuronext Brussels: FAGR: Together we create the future of personalizing medicine.
3+ YOEValidate pharmaceutical manufacturing equipment and control systems, prepare and execute validation protocols, perform calibration, support regulatory inspections, and work in cGMP environments.
EV Battery Manufacturing Validation Engineer - Holland, MI
Holland, Michigan, United States
OnsiteFull Time
ATC Drivetrain: Global automotive remanufacturer serving OEMs, aftermarket distributors, and consumers with remanufactured powertrain and drivetrain components.
Experience with EV battery testing, high-voltage diagnostics, CAN communications, automated test systems, manufacturing quality systems, and cross-functional problem solving. LSS preferred; data tools experience advantageous.
Battery Management Systems (BMS), CAN, CAN FD, UDS, Vector CANoe, CANalyzer, Vehicle Spy, PLCs, Ignition, LabVIEW, SQL, Python, Minitab, MATLAB, Power BI, JIT, Kanban, PFMEA, MSA, Gauge R&R, SPC, Control Charts, Cp/Cpk, Lean Six Sigma (LSS)
Phlow: Phlow is a private U.S. public-benefit pharmaceutical CDMO developing and manufacturing essential medicines and active pharmaceutical ingredients.
5+ YOEBachelor’s degree in a related technical field and 5–7 years of validation experience in regulated pharmaceutical, biotechnology, API, or manufacturing environments; expertise in qualification, process, cleaning, and computer system validation.
User Requirements Specifications (URS), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Performance Qualification (PPQ), Continued Process Verification (CPV), CIP, COP, HPLC, Veeva, DeltaV, Microsoft Excel
Valspec: An ESOP consulting firm providing digital and conventional validation and lifecycle services to life sciences manufacturers.
Bachelor's degree in engineering or a related technical discipline; process validation and PPQ experience in biopharmaceutical or pharmaceutical manufacturing; technical writing, qualification coordination, GMP, process validation, and FMEA knowledge.
Sharp Services: Private global pharmaceutical CDMO serving pharma and biotech companies with sterile manufacturing, clinical services, and commercial packaging.
3+ YOEBachelor’s degree in engineering or related field, 3+ years of manufacturing engineering experience, pharmaceutical manufacturing knowledge, process design and validation experience, and proficiency with engineering software.
ADMA BiologicsNasdaq Global Market: ADMA: Public U.S. biopharmaceutical manufacturing plasma-derived biologics for immune-compromised patients and people at risk of infection.
3+ YOEBachelor's degree in science or engineering and 3+ years of validation experience in a cGMP pharmaceutical or biological manufacturing environment; FDA adherence required.
5+ YOEFive to seven years of validation experience in pharma/regulated manufacturing; engineering degree preferred; strong IQ/OQ/PQ, CSV, GMP/FDA/GAMP knowledge; travel.
Mercury Marine: Mercury Marine is a Brunswick-owned manufacturer of marine propulsion systems, engines, parts, and services for recreational, commercial, and government boaters.
3+ YOEBachelor's in mechanical engineering, 3+ years relevant manufacturing experience, Lean manufacturing and process improvement experience, AutoCAD and Microsoft Office proficiency.