- Actalent (Cranbury, NJ)
- …equipment in the manufacturing facility. + Produce pharmaceutical products according to cGMP standards. + Adhere to Good Documentation Practices. + Coordinate with ... the Quality Assurance Department for line clearance after cleaning. + Collaborate with the Engineering Department or Production Supervisor for equipment/facility breakdowns. + Serve as a trainer to new employees and operators from other processing equipment. +… more
- System One (Pennington, NJ)
- …Support both Upstream and Downstream manufacturing operations in a cGMP -compliant environment. This role provides hands-on experience throughout the biologics ... production process - from cell culture to protein purification. REQUIREMENTS + High School Diploma or Associate's Degree with 1-5 years of relevant GMP experience OR + Bachelor's Degree in Biotechnology, Biochemistry, Microbiology, Chemical Engineering, or… more
- Bristol Myers Squibb (Summit, NJ)
- …to ensure compliance with applicable local, state, federal regulations (eg, OSHA, EPA, ISO, cGMP ). + Serve as the site lead for EHS data management systems, ensuring ... accuracy and timely reporting of key metrics and performance indicators. + Analyze S&OH performance data to identify trends, create dashboards, and present actionable insights to leadership. + Develop and deliver clear and impactful PowerPoint presentations… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …filtration, and potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements (FDA, EMA, ICH). ... + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). + Excellent communication, collaboration, and influencing skills. + Ability to work… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …the CMMS, facilities and equipment under strict compliance to OSHA, GDP, GLP, cGMP , federal, state and local regulations. **EDUCATION REQUIREMENTS** **:** + Two year ... Associate Degree in Science related to Pharmaceutical Development plus specialized (mechanical) training related to pharmaceutical processing equipment . + Proficiency in the use of computer programs/systems is essential. PD Mechanic as must maintain their… more
- Bristol Myers Squibb (Summit, NJ)
- …product Value Stream outputs according to Current Good Manufacturing Practices ( cGMP 's) following the current, approved Standard Operating Procedures (SOPs) and Work ... Instructions (WIs). + Maintains timing according to the production schedule to ensure on-time logistics. + Performs apheresis receipt of patient materials and prepares final product shipments for couriers. + Executes receipt and discard of ex-US Peripheral… more
- Bristol Myers Squibb (Madison, NJ)
- …such as Python, R, etc., is a plus. + Expert understanding of cGMP regulations and/or business and documentation processes. + Highly proficient in technical writing ... and technical presentations, contributing to broader external and internal scientific community as appropriate. + Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Excellent communication, writing, sense of urgency,… more
- ARUNDEL MACHINE (Emerson, NJ)
- …regulations, prepare submissions and maintain regulatory databases + Adhere strictly to all CGMP , FDA 21 CFR820, ISO 13485, EU MDR and company procedures to ensure ... the quality and integrity of the products and safety of the workplace + Keep Quality area organized and clean + Keep stock of Quality materials such as tip protectors, test materials, etc. + Conduct training on receiving and inspections and orientation for new… more
- Merck (Rahway, NJ)
- …(OSD) manufacturing & development experience. + Familiarity with Quality, Regulatory, cGMP , Safety & Environmental Policies and Procedures + Strong technical writing ... skills to prepare Standard Operating Procedures (SOP) and cGXP documents + Exceptional organizational and analytical abilities with a keen eye for detail + Strong computer skills with preference for SAP experience + Strong communication and interpersonal… more
- Bristol Myers Squibb (Summit, NJ)
- …and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements **Knowledge & Skills:** + Demonstrated expertise in Process ... Automation Systems, specifically DeltaV, and data collection (ie, OSI PI). + Expert understanding of S88, S95 and batch processing operations required. + Understanding of engineering documentation such as P&IDs, FS/SCRs, process flow diagrams, and standard… more