- System One (Monmouth Junction, NJ)
- …Shift) to support the packaging of pharmaceutical products in a cGMP -regulated environment. This role involves operating packaging equipment, ensuring compliance ... with batch records and FDA guidelines, and maintaining accurate documentation. The position offers a contract-to-hire opportunity with growth potential based on performance and business needs. Duties and Responsibilities: + Operate and monitor packaging… more
- Burns & McDonnell (Morristown, NJ)
- …management of change orders. + Applies knowledge and understanding of FDA, cGMP , and other concepts, practices, codes, and procedures within the industry. + ... Demonstrated ability to develop designs in new or renovated facilities which integrate equipment, processes, and people. + Experienced in developing Process Architect deliverables across the Life Sciences industry including but not limited to Animal Health,… more
- BeOne Medicines (Pennington, NJ)
- …gene assay and immune binding assays. + Working knowledge with USP/EP and cGMP /EU GMP regulations. + Familiar with instrument and equipment validation. + Impressive, ... demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Strong leadership/team management skills and experience. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical… more
- Lilly (Branchburg, NJ)
- …of sterility assurance and applied pharmaceutical microbiology + Understanding of cGMP 's, policies, procedures, and guidelines relating to sterility assurance + ... Demonstrated experience influencing site and network leaders to advance technical agenda projects **Additional Preferences:** + Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing… more
- BeOne Medicines (Pennington, NJ)
- …processes and facility design approaches, plus a solid understanding of cGMP requirements. + General knowledge requirements include all applicable building codes ... and related regulations, basic design, and construction methodology (particularly in the process and mechanical discipline), and expertise in project management methodologies. + High skills and competency in project management tools and activities (process,… more
- System One (Piscataway, NJ)
- …+ Level III: 10+ years (Bachelor's) or 8+ years (Master's) + Previous cGMP laboratory experience - required + Strong Quality Control experience in a manufacturing ... environment + Demonstrated expertise in small molecules and protein chemistry + Proficiency with HPLC (Empower), SDS-PAGE, ELISA, bioassays, and compendial assays + Ability to troubleshoot analytical data and interpret/report results accurately + Prior… 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
- Hovione (East Windsor, NJ)
- …of pharmaceutical product development * Possess solid knowledge of pharmaceutical cGMP and regulatory requirements * Good communication skills (verbal and written) ... * Proactive, dynamic self-starter who is a team player and communicates effectively at all levels * Skilled at managing processes and tools * Fluency in English is a requirement * Must have strong technical problem-solving skills, a commercial sense, be… more
- dsm-firmenich (Belvidere, NJ)
- …of personal/process control computers, Current Good Manufacturing Practices ( cGMP ), International Organization for Standardization (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… more
- Sokol Materials & Services (Skillman, NJ)
- …of new biopharmaceutical manufacturing facilities. + Basic knowledge of cGMP 's and multi-national biopharmaceutical/cell therapy regulations. + Basic knowledge of ... facility/clean room design, process, equipment, automation, and validation. + Intermediate strong verbal/written communication skills and ability to influence at all levels. + Intermediate ability to think strategically and to translate strategy into actions.… more
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