- Insmed Incorporated (San Diego, CA)
- …Preferred Skills, Experience and Education): 7+ years' hands-on experience in a validation role with responsibility for computer systems specifically LIMS, ... strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, ... assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification,… more
- ValSource, Inc. (Rahway, NJ)
- …cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients...which includes vessel spray coverage testing. Working on a computer to draft protocols, analyze data and write reports.… more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... leads. + Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. +… more
- Curia (Albuquerque, NM)
- …and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), environmental ... Senior Principal Validation Engineer in Albuquerque, NM Build your future...form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong… more
- Merck & Co. (Lower Gwynedd, PA)
- …metrics associated with quality lab operations, establish new/updated procedures, participate in the validation of computer or lab systems, and work across the ... laboratory notebooks, and other scientific applications-#ProjectAdvance#EligibleforERPRequired Skills: Clinical Testing, Computer System Validation (CSV), Detail-Oriented, Deviation Management,… more
- Insmed Incorporated (NJ)
- …an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage ... and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech,… more
- Curia (Albany, NY)
- …and team members to keep apprised of computerized system needs, impacts on computer validation , project validation status, and other relevant issues ... CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and… more
- Formation Bio (New York, NY)
- …that ensure Formation Bio and its vendor network comply with GXP, and Computer validation standards. Provide leadership and direction to the quality assurance ... (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for the Vice… more
- Parexel (Montpelier, VT)
- …acquisition and installation, performance or coordination of routine maintenance, computer system validation , and regulated systems retirement **Qualifications ... with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded… more
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