- AbbVie (Branchburg, NJ)
- …with high attention to detail, while practicing Current Good Manufacturing Practices ( cGMP ) in an FDA regulated environment Qualifications + High School diploma or ... GED required. Minimum of 4 years' experience as a Senior Instrument Technician or the equivalent. Associates Degree in electronics technology or equivalent is strongly desired. College course work and/or ASQ Certified Calibration Technician (CCT) certificate a… more
- Integra LifeSciences (Plainsboro, NJ)
- …preferred. + Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP . + 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, strong time… more
- Integra LifeSciences (Plainsboro, NJ)
- …effectively learn new skills is required. + Demonstrated working knowledge of cGMP and applicable regulatory requirements. + Strong technical writing and oral ... communication skills. Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin,… more
- Integra LifeSciences (Plainsboro, NJ)
- …electrical repair and diagnostic tools/ instruments skillfully. + Complete all cGMP documentation associated with calibration and maintenance tasks. + Review ... calibration SOPs for accuracy during routine calibration or when a new instrument is introduced into the calibration database. Create or revise the SOPs as needed + Willingness to perform other related tasks. + Able to work with minimal supervision. + Able to… more
- BeOne Medicines (Pennington, NJ)
- …experience. + Exposure to or direct experience with regulated environments (ie cGMP , OSHA, EPA). + Previous experience in a manufacturing or operations environment. ... + Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents. + Experience in managing small to medium-sized projects and outside vendors. + Effective written and verbal communications skills… more
- Lilly (Branchburg, NJ)
- …field and 6 months of experience working in a cGMP biopharmaceutical, pharmaceutical manufacturing, or pharmaceutical development environment. Experience must ... include a minimum of: 6 months of experience with cell culture and protein purification manufacturing; 6 months of experience with GMP requirements for a large-scale manufacturing facility; 6 months of experience working with statistical software; 6 months of… 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
- Edgewell Personal Care (Allendale, NJ)
- …as well as ongoing and future regulatory compliance planning and proof of cGMP . Lead the design of regulatory strategy pathways aligned with company objectives as ... well as the provision of regulatory guidance at all levels of the organization. Establish and maintain impactful working relationships with internal and external business partners as well as other stakeholders such as industry associations, lobbying groups,… more
- BeOne Medicines (Pennington, NJ)
- …any scientific experimental plans, data and reports. + Uphold all cGMP standards for process qualification, deviation investigations and all related documentation. ... + Utilize fundamental engineering principles relevant to bioprocess unit operations for scale-up and technology transfer. + Participate in and support on-site supervision and management of contract manufacturers as required by BeOne. **Technical/Skills… 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