- ThermoFisher Scientific (Waltham, MA)
- …Compliance & Inspection Readiness** + Ensure all IT programs meet global regulatory and validation standards (21 CFR Part 11, GxP, GAMP 5, EU Annex 11). + Maintain ... ongoing inspection readiness by ensuring complete validation documentation and traceability. + Partner with Quality and Compliance teams to prepare for internal and… more
- Bristol Myers Squibb (Manati, PR)
- …Manufacturing Process or three (3) years of experience in pharmaceutical manufacturing process . + Knowledge of preparation, formulation and filling ... the Parenteral Operations Department Qualification Curriculum. + Knowledge of all critical process parameters and their impact in product quality. + Knowledge in… more
- Merck (West Point, PA)
- … experience is strongly preferred + Knowledge of equipment and process validation **Required Skills:** Accountability, Audit Management, Automation, ... Operations organization supporting the thriving West Point site is seeking a Process Automation Engineer (Specialist, Manufacturing Automation) to join the team. Our… more
- Merck (West Point, PA)
- …drug substance and drug products, including stability studies, comparability assessments, process validation , and control strategy development aligned with ICH ... to define clear objectives, success criteria, and decision points for process studies; select fit-for-purpose tools (eg, ANOVA, ANCOVA, mixed-effects models). +… more
- Fujifilm (Pueblo, CO)
- …or Mechanical Engineering + 3 - 5 years of experience in the chemical process , semiconductor, food, or pharmaceutical industry plus background in plant or ... a broad array of products and services used throughout the semiconductor manufacturing process . **The Role** The Project Engineer role is expected participate in all… more
- Lilly (Concord, NC)
- …focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation . TSMS PAR Scientists will support one of either ... ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation… more
- GRAIL (Durham, NC)
- …United Kingdom. It is supported by leading global investors and pharmaceutical , technology, and healthcare companies. For more information, please visit grail.com ... Assay Development, Engineering Operations, and the Clinical Lab to lead process integration, improvement, monitoring, and troubleshooting. The ideal candidate brings… more
- Amgen (Cambridge, MA)
- … process improvements + Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation ... of engineers and scientists, as you use engineering principles to implement manufacturing process in a cGMP environment. + Provide solutions to a variety of… more
- J&J Family of Companies (New Brighton, MN)
- …and implement processes, tooling, and fixtures. + Collect data and analyze process performance and capabilities for company products, including new products and ... in-house processing. + Lead effort to develop and maintains process Failure Modes and Effects Analyses (pFMEAs) for company...+ Support the transfer of product lines and the qualification- validation efforts. + Other duties as assigned. These job… more
- Eurofins US Network (Centennial, CO)
- …is accurate.** **Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation ... and are key to preventing quality failures through proactive risk and process management. This role involves monitoring lab processes, conducting audits, analyzing… more