- J&J Family of Companies (Raritan, NJ)
- …and execution of system validation activities in accordance with regulatory cGMP 's, GAMP, ICH, and applicable regulations, good engineering practices and industry ... standard best practices. **Qualifications - External** **Education:** + Minimum of a Bachelor's or equivalent University Degree required; focused degree in Engineering, Science, or related field preferred. **Experience and Skills:** **Required:** + Minimum 4… more
- dsm-firmenich (Belvidere, NJ)
- …and 7PM -7AM + Knowledge and understanding of personal/process control computers, cGMP , ISO, environmental, regulatory and safety compliance. + Minimum of 1 to ... 4 years of experience required in power and steam generation or equivalent + Must be able to perform the essential functions of the job including but not limited to maintenance of process equipment in shop floor situations. The salary or hourly wage scale… more
- BeOne Medicines (Pennington, NJ)
- …and facility/utility space to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use. ... + Ensuring the QA Compliance of departmental SOPs (writing & revising), ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially. + Knowledgeable in cGMPs: 21 CFR Parts 11, 210, 211, and 600. + Demonstrated… more
- Aerotek (Mahwah, NJ)
- …+ Exposure to pharmaceutical manufacturing is advantageous. + Experience in a cGMP environment or clean-room is highly desirable. + Strong verbal and written ... communication skills. + Ability to work effectively in a team environment. + Capability to follow written and oral instructions with minimal supervision. **Pay and Benefits** The pay range for this position is $22.00 - $25.00/hr. Eligibility requirements apply… more
- Merck (Rahway, NJ)
- …creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP , etc.) are imperatives for the business. Responsible for establishing a ... Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or need. + Supply - Exercise judgement and decision making to ensure quality product is reliably… more
- Integra LifeSciences (Plainsboro, NJ)
- …skills. + Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred. + Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) ... preferred. + Ability to define problems, collect data, establish facts and draw valid conclusions. + Ability to work effectively in a cross functional environment. + Ability to integrate quality objectives across multiple functions. + Attention to detail and… more
- Sanofi Group (Ridgefield, NJ)
- …and commissioning of new electrical systems and equipment ensuring safety and cGMP compliance. + Repair or replace faulty electrical components, wiring, motors, ... drives, transformers, circuit breakers, and control panel components. + Utilize advanced testing equipment and diagnostic tools like multimeters and megohmmeter to identify electrical issues. + Interpret Programmable Logic Controller (PLC) ladder logic… more
- Bristol Myers Squibb (Summit, NJ)
- …assessment, and control strategy development. + Strong working knowledge of OSHA, cGMP , ACGIH TLVs, NIOSH RELs, and GxP compliance requirements. + Proven success ... leading cross-functional safety programs in regulated environments. **Preferred Requirements:** + Master's degree in Industrial Hygiene, Occupational Health, or related discipline. + Certified Industrial Hygienist (CIH), Certified Safety Professional (CSP), or… more
- Merck (Rahway, NJ)
- …and validation, drug product testing and analytical investigations in a cGMP environment, drug product and manufacturing process characterization, drug product ... stability studies, specification development, manufacturing process scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions. The successful… more
- Hovione (East Windsor, NJ)
- …pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. ... Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements. -… more