- Novo Nordisk Inc. (West Lebanon, IN)
- …fast-paced environment where priorities can change quickly, while adhering to our cGMP processes and documentation standards. Working in the cleanroom areas may ... with zero (0) years' experience Knowledge, Skills, and Abilities Knowledge of cGMP operations preferable The ability to understand and execute established written… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …efficiently, and supporting training of cleaning processes to run according to cGMP requirements. This is an onsite based position Monday-Friday at our bioproduction ... facility in West Lebanon, NH. This role will require on-floor support in our Grade C and Grade D clean room production areas. Working in the cleanroom areas may require wearing: hairnet, beard cover, frocks/coveralls, shoe covers, snood, face mask, sterile… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …running efficiently, supporting training of technicians to run according to cGMP requirements, ensuring routine preventative m aintenance and equipment repairs are ... carried out correctly. May be r esponsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer will work alongside Process… more
- Parexel (Indianapolis, IN)
- …equipment during audits + Ensure compliance with all regulatory requirements ( cGMP ) and internal policies and procedures **Required Skills and Experience** + ... Experience working within a regulated (GMP) laboratory + **Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems** + Familiarity with standalone computer system… more
- Lilly (Indianapolis, IN)
- …and inspection activities, contributes to process improvements, and ensures compliance with cGMP and safety requirements. This role also serves as backup to the ... improvement of existing manufacturing methods via Current Good Manufacturing Practices ( cGMP ). **Roles and Responsibilities of the Position:** + Produce drug… more
- CBRE (Lebanon, IN)
- …processes at client site. Leverage in-depth knowledge of project execution in cGMP environments to successfully deliver capital projects and programs. Interface with ... (PMBOK). Leverage a detailed understanding of asset lifecycle management in cGMP environments to successfully deliver projects. This includes Assessing Impact,… more
- Lilly (Indianapolis, IN)
- …improvement of existing manufacturing methods via Current Good Manufacturing Practices ( cGMP ). Roles and Responsibilities of the Position: + Produce radioisotopes ... and drug products following cGMP guidelines and resolve all production-related quality events in...and complete lab data notebooks as per cGLP and/or cGMP , as appropriate. + Adhere to all applicable procedures,… more
- Lilly (Lebanon, IN)
- …comply with safety rules and closely following approved procedures to ensure cGMP compliance. + Document all work by following Good Documentation Practices. + ... compliance with safety rules and closely following approved procedures for ensuring cGMP compliance. **Basic Qualifications:** + 480 Volt switch gear + High school… more
- Lilly (Indianapolis, IN)
- …Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for all products manufactured by third-party ... in quality audits of external manufacturing sites to assess compliance with cGMP , regulatory expectations, and Eli Lilly's quality standards. + Review and approve… more
- Lilly (Indianapolis, IN)
- …of BLUE projects, change controls and specifications following established cGMP processes and applicable procedures. + Coordinate communications with regulatory, ... and provide guidance ensuring printed materials are produced in compliance with cGMP . + Effectively utilize project management skills and available resources to… more
