- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development ... providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP … more
- ValSource, Inc. (Worcester, MA)
- …technically skilled leaders in Process/Process Equipment Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network ... support our clients’ Process Engineering programs within Pharmaceutical and Biotech GMP manufacturing facilities. This includes systems and equipment used in these… more
- ValSource, Inc. (Durham, NC)
- …commissioning, qualification, validation (CQV) of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Responsibilities are expected ... US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. Proficiency with Microsoft office including Word, Excel, and PowerPoint.… more
- ValSource, Inc. (Rahway, NJ)
- …exciting projects with our clients in the pharmaceutical and biotech and related GMP manufacturing industries throughout each of our regions in the US. The ... and equipment qualification activities, and ensuring compliance with FDA, GMP , and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface… more
- Cipla (Hauppauge, NY)
- …and conducting quality inspections. The role also ensures adherence to GMP and GDP standards, handles non-conformance issues, supports supplier management, and ... findings. Ensure all warehouse operations comply with Good Manufacturing Practices ( GMP ) and regulatory requirements. Participate in internal audits and ensure… more
- Merck & Co. (Durham, NC)
- …and Skills:Familiarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsPhysical requirements ... Systems (CMMS), Documentations, Engineering Processes, Equipment Maintenance, Facility Maintenance, GMP Compliance, GMP Operations, HVAC Systems, Lease… more
- Merck & Co. (Durham, NC)
- …automation documents, preventive maintenance, and SOPs toensure compliance with GMP and safety.Develops and supports corrective actions associated with automation ... skills and a proactive approach to problem-solvingPrevious experience in a GMP manufacturing related roleStrong written and verbal communication skills in… more
- Merck & Co. (Durham, NC)
- …to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns Coordinates with Site Engineering and ... completed in accordance with established safety, Good Manufacturing Practices ( GMP ), and calibration/maintenance procedures. Establish processes that ensure required… more
- Cipla (Fall River, MA)
- …to avoid time loss during any machine breakdown Prepare, review and update GMP documents to meet regulatory compliance and quality of product Prepare the facility ... CAPA in the block Ensure online documentation for any non-conformance to meet GMP by performing surprise checks Prepare and review the qualification, validation and… more
- Lundbeck (Bothell, WA)
- …design, optimize, and scale purification processes for biologics. Support production of non- GMP materials as needed, including production of tox study material in ... requirements. Support Process Sciences in technology transfer activities to GMP manufacturing facilities, ensuring compliance with regulatory standards. Required… more
