- Lilly (Indianapolis, IN)
- …assembly and packaging processes. You'll ensure robust design, integration, and validation aligned to global standards while meeting site-specific needs. **How ... Exception, Recipe Management, Equipment Management, and EBR authoring. + Support validation activities including authoring/reviewing of design specs, test plans, and… more
- Integra LifeSciences (Princeton, NJ)
- …URS documents, FRS and Configuration Specification documentation following Integra's Computer System Validation and Change control process to maintain the system ... analyzing business processes, evaluating user requirements and system specifications, process flows, group categories, terminology, states and activities, permissions,… more
- Amgen (New Albany, OH)
- …to manufacturing operations + Work closely with other business and IS Process Engineers to find opportunities to stop inefficient practices, simplify business ... and SAP EWM applications that support manufacturing, preferably biotechnology, pharmaceutical , or related industry. + Hands-on experience with computerized systems… more
- West Pharmaceutical Services (Exton, PA)
- …support design and development activities within West's Product Development Process demonstrating leadership and strategic thinking within a goal-oriented ... phases with a focus on design and qualification through verification and validation . + Create and edit product models/drawings. + Write engineering test protocols,… more
- Actalent (Columbus, OH)
- …chemical and physical analyses to support the development of pharmaceutical products, providing analytical support for regulatory submissions, and assisting ... with method validation and transfer activities. Responsibilities + Conduct chemical and...and physical analyses to support the development of manufacturable pharmaceutical products. + Provide analytical support for the release… more
- Cambridge Isotope Laboratories, Inc. (Tewksbury, MA)
- …high technology markets. CIL's growing customer base spans academia, pharmaceutical , medical diagnostic and semiconductor industries enabling collaborations with ... market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over...data in a scientific way to support development and validation work under GMP guidelines and SOP's + Troubleshooting… more
- Abbott (Abbott Park, IL)
- …competence. + 3+ years of experience in quality systems, qualification, and validation in a pharmaceutical / medical device environment. + Instrument ... competence. + 5+ years of experience in quality systems, qualification, and validation in a pharmaceutical /medical device environment. + A quality and… more
- Actalent (Chicago, IL)
- …maintaining GMP standards and supporting the release of high-quality pharmaceutical products. Responsibilities + Operate GC/HPLC instruments under GxP requirements ... activities; ensure completeness and accuracy of manufacturing records. + Lead method validation efforts per USP and other applicable regulatory standards. + Revise… more
- Lilly (Indianapolis, IN)
- …and their impact to the medical device design transfer and post-launch surveillance process . + Engage externally to ensure the organization stays current in the ... reports, and other related technical documentation. Oversee qualification and validation strategy for device and packaging processes. + Independently identify… more
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …Skills/Qualifications: Other Skills: Competencies: Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing ... Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation . + Prepares periodic… more