- BeOne Medicines (Pennington, NJ)
- …facility and then shift focus to hands-on execution and support of cGMP manufacturing operations. **Facility Start-Up** : Focused on activities required to design, ... execution + Acceptance testing and equipment/automation debugging + Technical training **Hands-On cGMP Operations** : Focused on execution of cGMP manufacturing… more
- Hovione (East Windsor, NJ)
- …with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications. - In the early designing phases, guarantee ... that cGMP and HSE requirements and adequate Engineering solutions are...review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated -… more
- BeOne Medicines (Pennington, NJ)
- …facility and then shift focus to hands-on execution and support of cGMP manufacturing operations. **Hands-On cGMP Operations** : Focused on execution ... Essential functions of the job include but not limited to: + Follow cGMP procedures to support manufacturing execution and automated recipes + Clean-In-Place (CIP) &… more
- Bristol Myers Squibb (Summit, NJ)
- …in a professional and timely manner. + Respond in accordance with cGMP policies and procedures. + Perform routine calibrations and controls troubleshooting. + ... paperwork, ie, Logbooks, Work Orders, Calibration Documentation in accordance with cGMP good documentation practices. + Use various testing devices and standards… more
- Bristol Myers Squibb (Summit, NJ)
- …with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . Functional responsibilities include ensuring manufacturing compliance with applicable ... manufacturing. + Must have sound knowledge and experience in FDA-regulated cGMP manufacturing operations and processes. + Must be action-oriented and… more
- System One (Cranbury, NJ)
- …in the production of solid oral dosage forms in a cGMP -regulated pharmaceutical environment. This role involves equipment setup, in-process testing, documentation, ... Complete all batch-related documentation, logbooks, and records in accordance with cGMP standards. Equipment Setup & Maintenance + Assemble and disassemble… more
- Kelly Services (Titusville, NJ)
- …preferred. **Experience and Skills:** Required: + A minimum of 8 years working in a cGMP regulated environment for Manager Level + A minimum of 5 years working in a ... cGMP regulated environment for Sr Specialist Level + Experience...oversight for pharmaceutical (or equivalent) production, including manufacturing operations, cGMP compliance, and non-conformance investigation. + Ability to work… more
- Kelly Services (Parsippany, NJ)
- …of Annual Product Reports (APRs). + Participation in internal and external cGMP audits. + Preparation, review, and approval of Standard Operating Procedures (SOPs). ... + Actively engage in and support internal and external cGMP audits related to the FPG site. + Lead...independently and proactively address issues. + Deep understanding of cGMP , 21 CFR 210/211, and other applicable regulations, standards,… more
- System One (Princeton, NJ)
- …on filled devices + Completes batch record and SOP documentation according to cGMP requirements + Enters data into electronic software systems (ie ERP) + Cleans ... years of manufacturing experience in pharmaceutical or medical device cGMP compliant production/pilot plant or recent college graduate with...1 hour). + Flexibility and attention to detail + cGMP and/or clean room experience is a plus System… more
- Kelly Services (Somerset, NJ)
- …will gain hands-on experience in deploying quality systems in a **regulated cGMP environment** , while contributing to continuous improvement efforts to enhance ... 11** ). + Uphold data integrity principles and maintain compliance with ** cGMP ** and company policies. Adhere to all **Environmental, Health, and Safety (EHS)**… more