- Merck & Co. (Rahway, NJ)
- …and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility ... will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability...and equipment are maintained and are suitable for both GMP and developmental use.- Author, review and approve … more
- Merck & Co. (Rahway, NJ)
- …review and approval of documentation to support Good Manufacturing Practice ( GMP ) clinical supply API manufacture, testing, release, and maintenance in support ... to API manufacturing in a complex, clinical supply development.- Review and/or approve GMP documents. Ensure all API are manufactured in compliance with cGMP and… more
- Merck & Co. (Rahway, NJ)
- …and routine maintenance of analytical equipment and instrumentation within the GMP environment.The key responsibilities of this role will include:Partner with ... excellence Onboard, qualify, and maintain laboratory equipment and instrumentation in both GMP and non- GMP environment Participate in laboratory computer system… more
- Aequor (East Syracuse, NY)
- …preferred. Working knowledge and experience in the biopharmaceutical development process, GMP , PAT, CMC and regulatory guidance, ICH guidelines, and compendial ... laboratory and office-based with occasional work in a classified GMP manufacturing environment. Dynamic, fast-paced, interactive, and entrepreneurial environment.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Small-Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and ... gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for… more
- Merck & Co. (Durham, NC)
- …quality, on-time delivery, and seamless operations in a dynamic GMP manufacturing environment.Primary Activities:Communicate effectively to Operations and scheduling ... maintenance activities are carried out in accordance with established safety, GMP , and calibration/maintenance procedures.Uses the SAP work order system to review… more
- Merck & Co. (Durham, NC)
- …maintenance activities are completed in accordance with established safety, GMP , and calibration/maintenance proceduresUpdate maintenance procedures to ensure work ... time management skillsFamiliarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsExperience with… more
- Merck & Co. (Durham, NC)
- …data collection techniques, and troubleshooting in compliance with SDLC, GMP , safety, and environmental regulations.- Actively support, participate and embrace ... Management, Environmental Regulations, Environment Health and Safety, Fast-Paced Environments, GMP Compliance, Good Manufacturing Practices ( GMP ), Healthcare… more
- Merck & Co. (Durham, NC)
- …Management experienceFamiliarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsExperience with ... GMP compliant calibration databasesExperience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or… more
- Merck & Co. (Durham, NC)
- …time management skillsFamiliarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsExperience with ... GMP compliant calibration databasesExperience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or… more
- Aequor (West Greenwich, RI)
- …done in the Rhode Island labs for this role. General lab experience/lab background, GDP/ GMP experience, ability to work in teams. 100% onsite - Essential CW Job ... activities: 1. Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring. 2. Perform testing and possible data… more
- Aequor (Vacaville, CA)
- …At least 75% of the candidate's time will be spent gowned into the GMP manufacturing space. The ideal candidate would have a technical understanding of and ... as the Roche Cedex Bio, Cedex HiRes, and Cobas b 221 in either a GMP manufacturing or QC lab environment. Experience with other analytical equipment and devices is a… more
- Merck & Co. (Durham, NC)
- …knowledge of DeltaVPreferredExperience working in a clean room or GMP /regulated manufacturing environment.Experience working on Clean Utility systems. #MSJR VETJOBS ... Improvement, Equipment Troubleshooting, Field Failure Analysis, Good Manufacturing Practices ( GMP ), Industrial Mechanics, Lockout Tagout, Maintenance Management, Maintenance Processes,… more
- Merck & Co. (Durham, NC)
- …of DeltaVPreferredExperience working in a clean room or GMP /regulated manufacturing environment.Experience working on Clean Utility systems.#MSJRCurrent Employees ... Electrical Maintenance, Equipment Commissioning, Equipment Maintenance, Good Manufacturing Practices ( GMP ), HVAC Systems, Hydraulic Systems, Industrial Mechanics, Instrumentation Systems,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and ... cell therapy.Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.Experience in supporting cell-based products is a… more
- Merck & Co. (Rahway, NJ)
- …under pressure.Demonstrates strong attention to detail.Process-oriented with familiarity of GMP requirements and working in a highly regulated industry.Experience ... Documentation requirements and processes pertaining to system management for GxP/ GMP applications.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (Durham, NC)
- …any new projects.- This includes SME support during routine internal and external GMP and Financial audits, QSAT actions, to ensure compliance.- This is a fast-paced ... coaching to ensure team success.SME support during routine internal and external GMP and Financial audits, input to QSAT actions, to ensure compliance.Support the… more
- Merck & Co. (Rahway, NJ)
- …is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in ... Data Analysis, Dosage Forms, Financial Research, Good Manufacturing Practices ( GMP ), Immunochemistry, People Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …improvement opportunities, and develop unbiased tangible and intangible value realized.Understanding of GMP with a strong motivation to build deep expertise in CMC ... Change Controls, Computer Technical Support, Cost Management, Financial Management, GMP Compliance, Incident Management, IT Business Solutions, Management Process,… more
- Aequor (Thousand Oaks, CA)
- …Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach. ... for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation,… more
