- Merck & Co. (Rahway, NJ)
- …& Controls ( CMC) , Pre-approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to our ... company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high-quality submissions for products that may include… more
- Merck & Co. (Rahway, NJ)
- …- Required Skills: Combination Products, Compliance Packaging, Deviation Management, Engineering Standards, ISO Standard, Management Process , Mechanical ... Job DescriptionThe Associate Director, Engineering , Packaging Commercialization will lead packaging development for...s are robust , packaging processes are efficient, and control strategies are integrated with both upstream and downstream… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDir, Engineering - Director, Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical Operations ... development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership… more
- Merck & Co. (Rahway, NJ)
- …Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management ... Process , Manufacturing Scale-Up, Mentorship, Packaging Engineering , Process Optimization, Risk Management, Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …in media/solution development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture ... biologics in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream… more
- Merck & Co. (Rahway, NJ)
- …Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA : Experience ... Validation, Manufacturing Quality Control , Manufacturing Scale-Up, Mentorship, Process Improvements, Protein Purifications, Regulatory Submissions, Technical… more
- Merck & Co. (Rahway, NJ)
- …applying knowledge in drug and device product development, such as manufacturing process development and validation, design control , risk management, material ... strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design, development, and… more
- Merck & Co. (Rahway, NJ)
- …suppliers with PO and invoicing issues, manage expedited payment requirements per regulatory requirements Contractor Invoice Management : Process purchase orders ... of our capital projects. - The Specialist will serve as a system and process support lead, acting as a subject matter expert for our procurement tools, particularly… more
- Merck & Co. (Rahway, NJ)
- …Conflict Resolution, Cross-Functional Teamwork, Customer-Focused, Design Control Process , Ergonomics Consulting, Human Factor Engineering , Human Resource ... Staff, Negotiation, Neuropsychology, Patient Safety, Post Marketing Surveillance, Prioritization, Process Engineering , Product Lifecycle, Product Lifecycle Management… more
- Merck & Co. (Rahway, NJ)
- …Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management ... Process , Manufacturing Scale-Up, Mentorship, Packaging Engineering , Process Optimization, Risk Management, Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …Cost Management, Driving Continuous Improvement, Global Sourcing, Inventory Control Management, Logistics, Logistics Management, Management Process , ... exert procurement influence, ensuring consistent application of sourcing across engineering , construction, equipment, and automation categories for all capital… more
- Merck & Co. (Rahway, NJ)
- …Network Orchestration including: product enhancements, cross-product considerations, process and method technical changes, robustness/quality/ productivity projects. ... alternatives need to be established. Education: Required: Bachelor's degree in Engineering , Science, Supply Chain Management or related field. Preferred: Master's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the platform process description and collaborate to the global change control process and global investigations.Maintain global program project portfolio and ... platform changes/improvements in a global manufacturing network and drive change management process from inception through regulatory approval to global site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Site Strategic Initiatives team. This role will specialize in manufacturing process optimization and provide dedicated engineering expertise related to new ... This individual's primary responsibility will be support of manufacturing process optimization through process modelling, new technology integration,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …around validation and comparabilityIndustry leading knowledge in technology transfer, process comparability, CMC regulatory guidelines and manufacturing in ... analytics scope in support of the approved Carvykti commercial process . At a technical level, the candidate will be...that ongoing manufacturing processes are in a state of control and, additionally, adhere to guidelines established for CPV.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …standards and GMP regulations.Conduct analytical testing of raw material/utility, in- process , or final product samples submitted to the QC laboratories.Perform ... quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/ Process Development.Job duties performed require routine exposure to and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a GMP Commercial Facility.Experience with Asset Change Control , Process /System Improvement, Asset Lifecycle activities/documentation.Excellent knowledge ... to meet clinical and commercial demand.RequirementsBachelor's Degree - Preferably in Engineering or Life Sciences.Minimum 10 years of Project Management experience… more
- Passaic Valley Sewerage Commission (Newark, NJ)
- Process Control Engineering and Regulatory Compliance Intern Overview IF YOU ARE A CURRENT PVSC EMPLOYEE PLEASE CLICK HERE ... of America Category: Process Control Description To provide process control engineering services for all physical, chemical and biological processes… more
- Passaic Valley Sewerage Commission (Newark, NJ)
- …and remote pump stations, and will assist the Director of Process Control Engineering and Regulatory Compliance by conducting studies and experiments ... Category: Process Control Description Position Summary: The Process Control Engineers will provide engineering services for all physical, chemical… more
- Merck (Rahway, NJ)
- …Manufacturing & Controls (CMC), Pre-approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to ... company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high-quality submissions for products that may include… more
