- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:We're looking for a Sr Manager, IT Clinical Systems Validation in the IT team to help us expand what's possible for ... technology trends, and industry best practices for relevance to clinical systems validation .Who You Are:You have a Bachelors degree in Computer Science or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification, process ... and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation , process validation , equipment, utilities,… more
- Syner-G BioPharma Group (Boston, MA)
- …production systems , with a concentration on computerized equipment and systems validation .Report writing experience for IQ, OQ, PQ, and CSV.Knowledge, ... (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems , equipment, and processes for (re)qualification/(re)verification.Support validation … more
- ValSource, Inc. (Durham, NC)
- …and sterilization validation of manufacturing equipment. Experience with cleaning validation , process and utility systems validation , laboratory ... Validation Specialist / Validation Engineer /... (CQV) of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Responsibilities are expected to include but… more
- Cipla (Hauppauge, NY)
- …Description for Validation Engineer Role Summary The purpose of the Validation Engineeris toensure that products, equipment, and systems meet all applicable ... adhering to a change management process. Supports the execution of equipment/ systems qualifications and validation protocols. Supports vendor's qualification… more
- Cipla (Hauppauge, NY)
- …IT Manufacturing, Packaging and WH Systems support including IT administration, Systems Validation , PLC Validation , Maintain Infrastructure & Security ... IT QC, QA, R&D and RA Systems support including IT administration, Systems Validation , Instrument Software Validation , Maintain Infrastructure & Security… more
- Cipla (Central Islip, NY)
- …IT QC, QA, R&D and RA Systems support including IT administration, Systems Validation , Instrument Software Validation , Maintain Infrastructure & Security ... QC Instruments/QA/R&D systems etc.,), Administration, CSV activities, and QC Systems validation and qualification Strong knowledge in handling QC Instruments… more
- Insmed Incorporated (NJ)
- …leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage cross-functional ... and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech, or… more
- ValSource, Inc. (Rahway, NJ)
- …qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Validation Execution: Field Execute and oversee ... with project management, good documentation practices, cGMP, & FDA validation methods and systems , ability to read...practices, cGMP, & FDA validation methods and systems , ability to read engineering documents, set priorities, and… more
- Formation Bio (New York, NY)
- …Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for the Vice President ... there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy will involve leadership and… more
