- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Required Master's Degree in Computer Science, Life Science, Engineering, or Information Systems - Preferred Experience10+ years of experience in GxP-regulated ... Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization.… more
- Merck & Co. (Rahway, NJ)
- …programs ranging from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Combination ... teams.Proven track record of applying analytical skills in product design, development, and validation .-Proven ability to lead team members of diverse skill sets… more
- BioAgilytix (Durham, NC)
- …build the rules, processes, and cloud pipelines that keep lab and business information accurate, secure, and easy to find. That means hands-on work designing Azure ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance ... MachinesThe ability to satisfactorily perform all types of industrial mechanical work as assigned. Lead the shift group of mechanics and serves as a role model within… more
- Merck & Co. (Rahway, NJ)
- … Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations...qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- Repligen (Rancho Dominguez, CA)
- …Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation ... are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Novo Nordisk Inc. (Durham, NC)
- …Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and ... practices, to include increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches etc. for optimization… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... initiatives requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for working with groups to provide start-up, commissioning, and qualification/ validation support of instrumentation and systems including on-the-floor ... Training, QC, EM, Operations Technical Support, Facilities and Engineering, Validation .Requirements B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field. Trade /… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... validation , with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills and principled verbal and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and sponsor various department… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… more
- Merck & Co. (San Francisco, CA)
- …seasoned Project Manager with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on helping the team build ... decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager, will be responsible for… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams. +… more
- Cognizant (Auburn Hills, MI)
- …Vehicle Triage, SWAT and Launch Support, etc. **What you'll be doing:** The Senior Lead Validation Engineer is responsible to lead electrical feature ... design, development, or test engineering . Experience in validation of complex systems and resource and...vehicle test properties before the start of every planned validation loop . Collect vehicle information such… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Lead Specialist, QA Validation & Engineering** Catalent Pharma Solutions is looking to hire a ** Lead Specialist, QA Validation & Engineering** to ... 8 CGMP manufacturing suites and cold storage warehousing. The ** Lead Specialist, QA - Validation & Quality...continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for… more
- Cognizant (Muskegon, MI)
- …have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist ... MES, ABB as well as other DCS and OT systems . **Requirements** : The Validation Lead...Purchase Plan Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this… more
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