Syner-G BioPharma Group: Provides CMC and regulatory services for life sciences companies.
4+ YOEBachelor's in life science or engineering, 4–7 years in biotech/pharma/medical device, strong knowledge of FDA cGMP, FMEA, CSV, and hands-on IQ/OQ/PQ validation experience.
Emergent BioSolutionsNYSE: EBS: Develops and manufactures vaccines and therapeutics for health threats.
8+ YOEBachelor's in engineering, chemistry, microbiology, or related field and/or 8 years of industrial validation experience. Requires validation expertise, GMP knowledge, technical writing, and systems experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Kaye AVS, SPC, DMAIC, CIP, SIP, PFDs, P&IDs
ReplimuneNASDAQ: REPL: Develops oncolytic immunotherapies for cancer treatment.
7+ YOE7+ years validation experience in cGMP environment, bachelor’s in scientific/engineering field (masters preferred), expertise with GMP utilities/equipment, validation lifecycle, technical writing, and regulatory compliance.
MerckXETRA: MRK: A science and technology providing healthcare, life science, and electronics solutions.
4+ YOEBachelor's (or Master's) in engineering/science with 3–4+ years in product/process development or validation, experience with IQ/OQ/PQ, FMEA/risk analysis, protocol/report authoring, and statistical analysis.
Eckert & Ziegler RadiopharmaFrankfurt Stock Exchange: EUZ: Manufacturer of radioisotopes and radiopharmaceutical products for medicine.
3+ YOE3–7 years pharma/biopharma validation experience with DQ/IQ/OQ/PQ, strong FDA cGMP knowledge, protocol and GMP documentation skills, and demonstrated project management (Gantt/milestone tracking).
Alcami: Provides contract drug development and manufacturing services.
5+ YOE5+ years direct validation experience, BA/BS preferred, experience with autoclave, temperature mapping, sterilization and GMP/GLP systems, calibration aptitude, strong technical writing and communication skills, up to 80% travel.
AppleNASDAQ: AAPL: Designs and sells consumer electronics, software, and online services.
Perform lab characterization and validation of analog and mixed-signal embedded circuits and collaborate with cross-functional teams to support mobile SoC launches.
Merck KGaAFrankfurt Stock Exchange: MRK: Develops pharmaceutical, life science, and electronics technologies.
2+ YOEBachelor’s degree in Biology, Biochemistry, Chemistry, or related field; 2+ years in biotechnology or pharmaceuticals, including validation, project management, QA, documentation practices, and root cause analysis.
Salesforce, Smartsheet, Microsoft SharePoint, Microsoft 360
Merck KGaA, Darmstadt, GermanyFrankfurt Stock Exchange: MRK: A science and technology in healthcare, life sciences, and electronics.
2+ YOEBachelor’s degree in Biology, Biochemistry, Chemistry, or related field; at least 2 years in biotechnology or pharmaceuticals, including validation, project management tools, quality assurance, documentation, and root cause analysis.
Salesforce, Smartsheet, Microsoft SharePoint, Microsoft 360, OSHA, EHS, ISO9001
Principal BioPharma Manufacturing Validation Engineer
Westborough, Massachusetts, United States
$119k-$170k/yrOnsiteFull Time
Astellas PharmaTokyo Stock Exchange: 4503: Global developing and manufacturing pharmaceutical therapies for patients.
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.
United States or Boston or Dallas or Chicago or Sunnyvale or Houston or Indianapolis or Raleigh
$100k-$130k/yrRemoteFull Time
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
5+ YOEBachelor's degree in engineering,5+ years leading process validation in biologics,knowledge of cGMP and global regulatory requirements,statistical and risk tools (pFMEA,DOE),technical writing and root cause analysis,ability to travel ~15%.
Verista: Provides compliance, automation, and validation services to life sciences.
7+ YOEBachelor's degree in a related discipline and approximately 7+ years of CSV, CSA, or computerized-equipment validation experience in regulated life sciences; GMP, GxP, data integrity, and validation software experience required.
Ridgefield or Teterboro or Greenville or Plainville
$113k-$169k/yrOnsiteFull Time
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
8+ YOEAdvanced degree with 8+ years validation experience or Bachelor's with 10+ years; strong cGMP validation experience across equipment, utilities, systems, cleaning, and analytical instruments; leadership, technical writing, risk assessment, and data integrity expertise.
CognizantNasdaq: CTSH: Provides IT consulting and digital business process services.
Experience in Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11, GAMP 5; lab systems validation in pharmaceutical/GLP/GMP/GCP environments; test execution and regulatory audit remediation.
InsuletNasdaq: PODD: Manufactures wearable tubeless insulin pumps for diabetes care.
2+ YOEBachelor's degree with 2+ years of relevant experience or Master's with 1 year; experience in medical device manufacturing, process validation, data analysis; ISO 13485/QMS familiarity; FDA guidelines knowledge.
New York City or Atlanta or Charlotte or Chicago or Washington or Boston or Florham Park or Dallas or Philadelphia
$155k-$410k/yrOnsiteFull Time
PwC: Providing audit, tax, and management consulting services to businesses.
8+ YOEBachelor's degree, at least 8 years' experience, expertise in data validation, analytics, visualization, and client leadership; familiarity with databases, cloud platforms, and ML tools preferred.
Alteryx, Python, Power BI, Tableau, Databricks, MS SQL, AWS, Azure, GCP, SAS
MarvellNASDAQ: MRVL: Designs and develops high-performance semiconductor and infrastructure solutions.
3+ YOEBachelor's (or Master's/PhD) in CS/EE,3+ years (Master's) or 5+ years (Bachelor's) validating SoCs/ASICs, hands-on lab debugging, high-speed interfaces, scripting (Python/Perl/Shell), C/C++, and Linux.