- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and PLC'sExperience with plant start-up, commissioning, and qualification and process improvement.Education Requirements Bachelor's Engineering degree required; ... Position Summary The Engineering Director is directly responsible for leading the...and commissioning of facility systems, as well as all process and laboratory equipment. Direction and leadership to the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and ensures the successful day-to-day operations of the Automation Engineering department.Generate, review, approve and control departmental documentation ... Position Summary The Manager of Automation Engineering leads Automation Engineers and contractors responsible for instrumentation and controls of manufacturing… more
- Merck & Co. (Durham, NC)
- Job Description GENERAL SUMMARY The Engineering , Maintenance and Site Services (EMSS) organization continuously improve the reliability of the Durham Site operations ... an Associate Director opening for the Teknika maintenance and Engineering team. The selected candidate will manage the ...facility. The Teknika Facility handles and End to End process and part of the main equipment includes all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to safety, environmental, quality, compliance, productivity, yield, and cost. Implement process improvements within the change control system. Recognize and ... for process changes/improvement. Partner with all stakeholders to implement process improvements. Assure regulatory compliance and technical feasibility of… more
- Merck & Co. (North Wales, PA)
- …position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across the ... patterns and disease progression, answer clinical development questions, and support regulatory submissions.- In this role, the principal statistical programmer will… more
- Merck & Co. (Durham, NC)
- …adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.Develop standard operating procedures (SOPs), engineering ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... and other groups as required.- Responsible for supporting: - Process Equipment (eg tanks/bioreactors, filtration skids, chromatography columns)-Support Equipment (eg… more
- Merck & Co. (Durham, NC)
- …ManagerProvides technical specifications and information to Quality, Manufacturing, Process -Project EngineersAids in the development of SOPs, engineering ... Refrigeration is accountable for providing maintenance and troubleshooting supporting vaccine process equipment operations. Key Functions Work Independently and as a… more
- Merck & Co. (Rahway, NJ)
- …between systems and devices.Apply expertise in control systems and control strategies to optimize process performance.Actively participate in site tier ... regulatory requirements.Execute and develop appropriate system validation, change control , and testing documentation.Maintain familiarity with system life cycle… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …be responsible for the following areasChange Management - Assure that the engineering department adheres to regulatory , and company change management ... processes. Quality by Design (QbD) - Participate in QbD activities with engineering to increase process capability, reduce product variability and defects… more
- Novo Nordisk Inc. (Boulder, CO)
- …and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, Colorado ... Specialist, API Manufacturing works with Chemical Development, Analytical Services, Engineering , Facilities, EH&S, Program Management and Quality Assurance. Essential… more
- Merck & Co. (Durham, NC)
- …Raman, and Mass Spec equipment, supporting Bulk Chemical equipment, implementations of process change control , Delta V Network and troubleshooting in compliance ... person is primarily responsible for supporting qualification of Fermentation Process Automation at our Company's Durham, NC facility. Responsibilities include:-… more
- Catalent (Harman, WV)
- …Quality Management Systems (QMS) to ensure the site is compliant with regulatory , Corporate, and customer requirements. They are responsible for establishing and ... of Quality-Maryland is responsible for Quality, Validation and Quality Control and is the most responsible person for batch...as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and… more
- Merck & Co. (Millsboro, DE)
- …other groups such as HR, QC, BTS, Biosafety, EHS, and Maintenance & Engineering and will participate in all institutional plans involving renovation or construction ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Catalent (Harman, WV)
- …core quality systems, including investigation/deviation management, CAPA tracking, change control , risk management, supplier quality, audits and inspections, raw ... the QA Systems staff supporting Investigation/Deviation/ CAPA Management, Change Control , Risk Management, Quality Metric Tracking responsibilitiesBuild effective teams… more
- Merck & Co. (Rahway, NJ)
- …(RaDS) value team in Our Company's R&D IT brings together product management, engineering , and data science expertise to enable data and technology products and ... our organization's target and biomarker discovery, chemistry, Biologics, Vaccines, safety, and process and analytical R&D efforts. The ideal candidate will possess a… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and reporting. Develops and improves site policies, prepares and submits regulatory reports, independently track recurring regulatory reports & permitting ... site Radiation Safety Officer Alternate Site Security Officer to administer access control systems (card access, biometrics, key control ) Environmental & Waste… more
- Insmed Incorporated (Bridgewater, NJ)
- …support of Insmed Person In Plant (PIP).Responsible for QA representation in Design Control Process for medical device products and combination products.Lead the ... Procedures relating to areas of responsibility including product release, design control , etc.Act as company's representative during regulatory agencies and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated ... report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standard methodology. Oversee applications support groups' system validation and change control process . Develop information system roadmaps.Provide such reports ... include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance,… more
