27 aseptic process validation engineer jobs at 20 companies in United States

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Senior Specialist, Associate Aseptic Process Validation Engineer
Devens, Massachusetts, United States
$88k-$106k/yr OnsiteFull Time
Bristol Myers Squibb
Bristol Myers SquibbNYSE: BMY: Develops and manufactures innovative prescription biopharmaceutical medicines.
2+ YOEBachelor's in science/engineering required, minimum 2 years biopharma operations experience, knowledge of cGMP, aseptic processing/validation and audits, strong communication and documentation skills.
1mo
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Senior Specialist, Associate Aseptic Process Validation Engineer
Devens, Massachusetts, United States
$88k-$106k/yr OnsiteFull Time
Bristol Myers Squibb
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
2+ YOEBachelor\u0019s in science/engineering, 2+ years biopharmaceutical operations experience, knowledge of cGMP and aseptic processing/validation, audit experience, strong written/verbal communication.
2mo
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Senior Engineer, Process Validation
United States or Boston or Dallas or Chicago or Sunnyvale or Houston or Indianapolis or Raleigh or Fargo
$100k-$130k/yr RemoteFull Time
Danaher
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
5+ YOEBachelor's or master's in engineering, 5+ years process validation in biologics, knowledge of cGMP and global regulatory requirements, risk assessment/statistical analysis (pFMEA, DOE, control charts), sterile aseptic fill-finish experience, technical writing and mentoring skills.
pFMEA, DOE, control charts
3d
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Process Validation Engineer (Fill Finish)
East Greenbush, New York, United States
$62k-$110k/yr OnsiteFull Time
Regeneron Pharmaceuticals
Regeneron PharmaceuticalsNASDAQ: REGN: Discovers and develops medicines for serious diseases.
2+ YOEBachelor's degree in engineering preferred; 2+ years relevant experience required, with aseptic processing, fill finish, technology transfer, drug product development, or biopharmaceutical validation preferred.
IPA
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Staff Engineer – Process & Cleaning Validation
Zebulon, North Carolina, United States
OnsiteFull Time, Contract
PM Group
PM Group: International project delivery firm for high-tech industrial facilities.
8+ YOEBachelor's in engineering/chemistry/life sciences, 8+ years process/cleaning validation in regulated sterile/aseptic manufacturing, strong cGMP knowledge, technical writing, data analysis, and cross-functional collaboration.
1mo
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Staff Engineer – Process & Cleaning Validation
Zebulon, North Carolina, United States
OnsiteContract
PM Group
PM Group: International engineering, architecture, and project management services firm.
8+ YOEBachelor's in engineering/chemistry/life sciences, 8+ years process or cleaning validation in regulated sterile/aseptic manufacturing, strong cGMP knowledge, PPQ experience, technical writing and analytical skills.
2mo
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Staff Validation Engineer, Media Fills
Greenville, North Carolina, United States
OnsiteFull Time
Thermo Fisher Scientific
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
8+ YOE8+ years in pharmaceutical/biotech validation; aseptic processing and media fill experience; sterile manufacturing background; strong technical writing; ability to lead validation projects.
GMP, cGMP, validation protocols, procedures, optimization, risk assessment, documentation
1mo
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Process Engineer
Morgantown, West Virginia, United States
OnsiteFull Time
Mountaintop Beverage
Mountaintop Beverage: Aseptic and extended shelf-life beverage manufacturing and-packing facility.
2+ YOEProvide process engineering support for aseptic beverage manufacturing, perform validation and root cause analysis, support equipment commissioning, and assist capital projects; 2+ years engineering experience preferred.
Microsoft Office Suite
4w
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MSAT Process Engineer II
Billerica, Massachusetts, United States
$89k-$148k/yr OnsiteFull Time
Lantheus
LantheusNASDAQ: LNTH: Develops and commercializes radiopharmaceutical and diagnostic imaging products.
6+ YOEBachelor's in engineering/chemistry,6+ years pharma sterile manufacturing experience,strong cGMP/aseptic/process validation knowledge,investigation and technical writing skills,proficiency with Excel and document/control systems.
Microsoft Excel, TrackWise, CATSWeb, Microsoft Word, Microsoft PowerPoint, Microsoft Project
1mo
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Validation Engineer and CQV
Phoenix or Chandler
$50k-$60k/yr OnsiteFull Time
Medivant Healthcare
Medivant Healthcare: Manufactures sterile injectable generic medications for hospitals and clinics.
2+ YOEBachelor's in life sciences, 2–3 years relevant experience, knowledge of aseptic/sterile processing and cGMP, strong documentation and communication skills.
2mo
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Senior Process Engineer
Brentwood, Missouri, United States
OnsiteFull Time
Kindeva Drug Delivery
Kindeva Drug Delivery: Develops and manufactures complex drug-device combination delivery systems.
3+ YOEBachelor's in engineering required; 3+ years cGMP sterile pharmaceutical/biopharma manufacturing experience; expertise in aseptic fill-finish, isolators/RABS, validation, PLC/HMI/SCADA, SolidWorks/AutoCAD Inventor, and data analysis tools.
SolidWorks, AutoCAD Inventor, PLC, HMI, SCADA, Microsoft Excel, Minitab, JMP, OSIsoft PI
2mo
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Manufacturing Process Engineer
Bedford, New Hampshire, United States
OnsiteFull Time
PCI Pharma Services
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
3+ YOE3-6 years in pharma cGMP environment; aseptic filling experience; leadership of floor activities; data-driven root cause analysis; strong communication; ability to draft SOPs and support qualification/validation.
MS Office, Data analysis tools, Aseptic Filling Isolator equipment
1d
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Sr. Engineer, MS&T – Aseptic Drug Product
Durham, North Carolina, United States
$114k-$212k/yr OnsiteFull Time
Novartis
NovartisSIX Swiss Exchange, NYSE: NOVN, NVS: A global healthcare developing and manufacturing medicines.
6+ YOEBachelor's degree with 6+ years, master's with 4+ years, or doctorate with 2+ years in biopharmaceutical manufacturing; requires GMP, aseptic fill-finish, sterile drug product, tech transfer, validation, and process improvement experience.
1d
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Sr. Engineer, MS&T – Aseptic Drug Product
Durham, North Carolina, United States
$114k-$212k/yr OnsiteFull Time
Novartis
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
6+ YOEBachelor's in a relevant technical field plus 6+ years of biopharmaceutical manufacturing experience, or equivalent master's/doctorate pathway; requires GMP, aseptic manufacturing, process validation, tech transfer, analytical, and technical leadership experience.
1mo
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Process Engineer II (MSAT) - Dayshift
Blue Ash, Ohio, United States
$70k-$96k/yr OnsiteFull Time
Resilience
Resilience: Provides contract development and manufacturing services for complex medicines.
Experience/training in mechanics, hydraulics, pneumatics, vacuum, electronics, PLC/HMI/Historian, vision systems, aseptic/unit operations, validation and tech transfer; strong data analysis, root cause analysis, cross-functional communication, and problem-solving skills.
Programmable Logic Controllers (PLC), HMI, Historian/reporting, computerized systems, vision systems, URS, FAT, SAT, IQ/OQ/PQ, Six Sigma
1mo
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Product Launch & Lifecycle Engineer III/IV - Aseptic Processing / Sterile Manufacturing
Columbus, Ohio, United States
HybridFull Time
Boehringer Ingelheim
Boehringer Ingelheim: Researches and develops pharmaceutical products for humans and animals.
10+ YOEB.S. in chemistry/engineering/pharmacy or related field plus substantial pharma/process/packaging engineering experience (10+ years typical), expertise in process/packaging transfer, validation, problem solving, and project leadership.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook
1mo
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Associate Sterility Assurance Engineer
Chaska, Minnesota, United States
$68k-$78k/yr HybridFull Time
Lifecore Biomedical
Lifecore BiomedicalNasdaq: LFCR: Manufactures sterile injectable pharmaceuticals and high-quality hyaluronic acid.
0+ YOEBS in Engineering or Life Sciences, up to 2 years quality experience (sterility assurance preferred), background in aseptic processing/cleaning validation/sterilization, risk assessment and quality improvement tools experience.
FMEA, FTA, DMAIC, Process mapping
2d
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6485 - Project Engineer / Project Engineer 2
Indianapolis or Fishers
$85k-$127k/yr OnsiteFull Time
Verista
Verista: Provides compliance, automation, and validation services to life sciences.
Requires hands-on VHP cycle development and qualification for pharmaceutical isolators, aseptic processing knowledge, BI placement and PQ experience, GMP validation expertise, technical writing, troubleshooting, and cross-functional communication.
1w
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Biologic Process Development Scientist
Irvine, California, United States
$111k-$211k/yr OnsiteFull Time
University of California, Irvine
University of California, Irvine: Public research university offering higher education and academic degrees.
2+ YOEMaster’s or PhD in a relevant science or engineering field, 2+ years of flow cytometry and aseptic cell culture, GMP/GLP knowledge, assay validation, SOP writing, and human tissue experience.
qPCR, Flow Cytometry, ELISA, Standard Operating Procedures (SOPs), Batch Records, Biosafety Cabinet, Centrifuge, Autoclave, 21 CFR 210, 21 CFR 211, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
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Sterilization Assurance Quality Engineer
Durham or Tewksbury
$67k-$92k/yr OnsiteFull Time
Corning
CorningNYSE: GLW: Develops and manufactures specialty glass, ceramics, and optical fiber.
1+ YOEBachelor's in life sciences/chemistry/engineering, 1+ years sterilization/aseptic processing experience in manufacturing, knowledge of sterility assurance principles and ISO standards, ability to review microbiological data and support validations.