- Danaher Corporation (Waltham, MA)
- …5+ years of experience in managing complex facilities within a regulated environment. Eg, GMP , FDA , MHRA, HTA + Bachelor's degree or equivalent, with direct ... experience interfacing with engineering, or real estate, or project management, and/or corporate real estate + 5+ years' experience in a senior management role across laboratory/pharmaceutical facilities (multi-site) or other operational role with relevant… more
- ThermoFisher Scientific (Boston, MA)
- …(Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards **Job Description** At Thermo Fisher Scientific, you'll ... Protein Titer, SoloVPE, or impurity methods. + Familiarity with GMP , CLP, and regulatory guidance such as ICH, USP/EP/JP,...designing method transfer and validation studies per ICH and FDA guidelines is highly desired. + Prior experience with… more
- Sanofi Group (Framingham, MA)
- …processes + Regulatory Knowledge: Familiarity with pharmaceutical industry regulations, including GMP and FDA standards + Problem-solving: Excellent analytical ... and problem-solving skills to address technical issues **Qualifications** + Bachelor's degree in Engineering or Science and 12+ years of CQV or relevant experience, or + Master's degree in Engineering or Science and 10+ years of CQV or relevant experience + 5… more
- Stantec (Devens, MA)
- …in a fast-paced, multi-project environment with cross-functional teams. - Familiarity with GMP regulations, FDA standards, and validation protocols. - Experience ... supporting capital projects or facility upgrades in regulated environments. - Understanding of risk-based scheduling and project lifecycle in Life Sciences industry. Education and Experience - Bachelor's degree or equivalent in Engineering, Construction… more
- Mitsubishi Chemical Group (Wilmington, MA)
- …6. Experience in IQ,OP,PQ processes 7. Familiarity with 5S/6S systems 8. GMP or GLP and/or FDA manufactured component experience/knowledge preferred\ 9. ... Familiarity with basic computer functions desired. 10. Must have good mechanical aptitude. 11. Able to maintain production reports/records as required. 12. Able to perform basic set-ups on these machines and tools that are used in them. 13. Must be able to… more
- BioLife Plasma Services (Boston, MA)
- …tasks require prolonged glove wear **Preferred Qualifications** + Familiarity with SOPs, GDP, GMP , CLIA, and FDA regulations + Experience working in a regulated ... industry or high-compliance environment **We Offer Comprehensive Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company-paid holidays + Tuition… more
- Eliassen Group (Westborough, MA)
- …working knowledge of FDA 21 CFR 820, ISO 14971, IEC 60601, GMP , and related standards. **Experience Requirements:** . 10+ years in medical devices with proven ... Geometric dimensioning and tolerance . Strong working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP ...of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …analysis, etc. required for new and existing products. + Working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as ... dimensioning and tolerance. + Must have working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP ...of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the… more
- BioLife Plasma Services (Boston, MA)
- …**PREFERRED QUALIFICATIONS:** + Associates or Bachelor's Degree + Experience working with SOPs, GDP, GMP , CLIA, and the FDA + Experience working in a highly ... regulated or high-volume retail environment + Excellent interpersonal, organizational, technical, and leadership skills \#LI-Remote **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in… more
- BioLife Plasma Services (Boston, MA)
- …tasks require prolonged glove wear **PREFERRED QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP , CLIA, and the FDA + Experience working in a highly ... regulated environment **We Offer Comprehensive Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company paid holidays + Tuition reimbursement +… more