- Merck & Co. (Rahway, NJ)
- …expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and ... deep knowledge in device design, requirement management, design verification, automation/ process development, design validation, and control strategy.Knowledge… more
- Merck & Co. (Rahway, NJ)
- … validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer ... documentation in support of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, … more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Sr. Tech, Engineering is a member of the Engineering team providing technical support to ... validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team… more
- Merck & Co. (Durham, NC)
- …adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipmentDevelop standard operating procedures (SOPs), engineering ... written documentation of activities. Accountable for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Merck & Co. (Rahway, NJ)
- …procurement analysts.Qualifications and ExperienceEducation Minimum Requirement:- Bachelor's Degree and advanced degree in an engineering , chemistry, biology, or ... Cost Management, Decision Making, Financial Acumen, GMP Compliance, Inventory Control Management, Logistics, Logistics Management, Management Process , Packaging… more
- Merck & Co. (North Wales, PA)
- …trials and assay metadata generated from these collections.Embed automated quality control checks and validation rules directly into data pipelines, ensuring our ... or Ph.D. (with 4 years) in bioinformatics, computer science, data science, engineering , data analytics, life sciences or other related field and relevant… more
- Cipla (Fall River, MA)
- …product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures ... and finished products through approval of respective COA. Review of engineering records such as temperature and humidity data calibrations, preventive maintenance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge and expertise in support of GMP investigations, change controls, document control , process improvement, process validation and data ... life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Cipla (Fall River, MA)
- …of manufacturing/ engineering non-conformances. Review and approval of manufacturing/ engineering change control , deviation investigation and CAPAs. Review ... product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management, resource planning, and fiscal awareness is preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ... degree in engineering or related field or equivalent experience required. Advanced degree and PMP certification strongly preferred.A minimum of 7 years of… more
- Merck & Co. (Rahway, NJ)
- …inspection. Education Minimum Requirement:- BS in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology); advanced degree ... Practices (GMP), Immunochemistry, Interpersonal Relationships, Manufacturing Processes, Manufacturing Quality Control , Microbiology, Molecular Microbiology, Physiology, Process Improvements,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Administration, Engineering , Life Sciences, or a related field is required. Advanced degree (MBA, MS) or relevant certification (eg, CPIM, CSCP, Lean/Six Sigma) ... life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering Quality Control , Operations Technical Support, Supply Chain and ... life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ... standards and GMP regulations.Conduct analytical testing of raw material/utility, in- process , or final product samples submitted to the QC laboratories.Perform… more
- Cipla (Fall River, MA)
- …to end business processes to have the capability to propose system changes, process transformations in line with the evolving business requirements. SAP Support for ... stakeholders Multi-Functional teams across regions eg Manufacturing, Packaging, WH, QC, QA, Engineering , Finance, HR etc. and IT Business Partners and other IT… more
- Cipla (Central Islip, NY)
- …Management, Finance, Engineering or a related field. An MBA or advanced degree is preferred. Relevant certifications such as Certified Professional in Supply ... with company objectives. Lead efforts to identify opportunities for cost savings, process improvements, and risk mitigation. Develop, manage and monitor RFQ (Request… more
- Insmed Incorporated (NJ)
- …etcAdditional duties as assignedWho You Are:BS degree in Life Sciences, Chemistry, Engineering , or related discipline; advanced degree (MS, PhD, PharmD) strongly ... phase-appropriate compliance.Actively represent QA in technical development activities, including process development, method validation/transfer, formulation work, and scale-up.Drive phase-appropriate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ... 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
- Cipla (Fall River, MA)
- …product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures ... this position include but are not limited to the following: Perform in- process testing (eg, weight, thickness, hardness, disintegration, friability, etc.) as per… more
- Insmed Incorporated (NJ)
- …Committee and Board of Directors.Establish and maintain governance frameworks and control structures consistent with NIST and FDA data protection standards.Partner ... Oversight: Oversee the CSV team, validation strategy and continuous process improvementEnsure compliance with GxP regulations and industry standardsFamiliarity with… more
