- Merck & Co. (Rahway, NJ)
- …Qualification and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary ... reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation ... plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP… more
- Eisai, Inc (Nutley, NJ)
- …software applications development/support in the pharmaceutical or related industries, and system validation methodologies.Excellent technical skills in SAS ... with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively… more
- Merck & Co. (Durham, NC)
- …multi-stage refrigeration systems ).Good oral and written communication skillsProficiency in computer systems and applications including but not limited to:- ... steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System … more
- Catalent Pharma Solutions (Somerset, NJ)
- **INTERNET POSTING** ** ** **Job Title:** Manager Computer System Validation and Data Integrity **City:** Somerset **State** : NJ **JOB DESCRIPTION** : ... and compliance resource, bringing forth opportunities for the implementation of new world-class systems and leverage existing systems for the assurance of GMP… more
- Bristol Myers Squibb (Summit, NJ)
- …place than here at BMS with our Cell Therapy team. The Computer Systems Validation (CSV) Manager supports the successful implementation of manufacturing ... of experience in pharmaceutical cGMP environment. + 5 years of hands-on Computer Systems Validation experience. + 3 years of experience with configuring… more
- Catalent Pharma Solutions (Harmans, MD)
- **Job Title:** Manager , Computer Systems Validation **City:** Harmans **State** : MD **JOB DESCRIPTION** : + Serve as the QA-CSV liaison with the ... and Validation organizations to support SaaS enterprise computer systems validation of Gene...Guidance's on electronic data integrity. + Support GMP manufacturing Computer System Validation including Pall… 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 ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
- BeOne Medicines (San Carlos, CA)
- …SAS, WinNonlin, VerifyPlatform, DocuSign, Medidata and Oracle CTMS; (5) Authoring and testing computer system validation deliverables in accordance with 21 ... BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Senior Manager , Systems Validation in... system access review documentation, etc. Maintain computerized system validation documentation. Telecommuting is an option.… more
- CACI International (Houston, TX)
- …integrated Verification and Validation (V&V) of the on-board, autonomous Vehicle Systems Manager (VSM) and Autonomous Systems Management Architecture ... Lunar Gateway Autonomous Control System Verification and Validation (V&V) Software Systems Engineer Job Category:...USG facilities. + BS in Electrical, Mechanical, Aerospace, Software, Computer or Systems Engineering, Computer … more
- Curia (Rensselaer, NY)
- …team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems ... functional areas across the organization to maintain and improve computer system validation processes to...experience working in a cGMP regulated industry specific to computer systems validation + … more
- System One (Bellevue, WA)
- …experience in nuclear safety software verification and validation activities and system transient analysis computer code benchmark. * Familiarity with EMDAP ... Design Basis Accident (DBA) Without Radionuclide Release * Nuclear safety analysis computer code assessment, verification and validation The Senior Safety… more
- Astrix Technology (Atlanta, GA)
- …Bachelor's in chemistry or related field.Must have 2 years' experience with computer systems validation within the pharmaceutical or chemical ... ** Validation Manager ** **_Duties:_** Supervise technical teams...proposals. Lead Validation Projects and manage the validation lifecycle of computer systems ,… more
- TD Bank (Mount Laurel, NJ)
- …this role. **Line of Business:** Risk Management **Job Description:** The Senior Manager , Quantitative Analytics oversees and lead a team of Quantitative Strategist ... to the team and others as needed. The Senior Manager , Quantitative Analytics also leads the advanced quantitative models'...strategy and decisions. **This role is to lead the validation of Pre-Provision Net Revenue (PPNR) models used in… more
- NVIDIA (Santa Clara, CA)
- …work, to amplify human creativity and intelligence. NVIDIA is looking for motivated System /Board Design Validation Engineers to use your creativity to work on ... the growth of the PC gaming market, redefined modern computer graphics, and revolutionized parallel computing. More recently, GPU...the highly inventive team. What you'll be doing: + System /board level debug and validation of NVIDIA… more
- Novo Nordisk (Bloomington, IN)
- … validation + Understand other validation technical disciplines, such as cleaning, computer system validation , and process validation , and be able ... validation + Understand other validation technical disciplines, such as equipment validation , computer system validation , and process … more
- PCI Pharma Services (Rockford, IL)
- …instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . ** Computer Validation Focus:** _Associate's Degree in ... protocols, validation statements, reports, summaries, and master validation plans for new customer/product/ system project launches... computer tasks and have some experience with computer systems considered to have an impact… more
- Takeda Pharmaceuticals (Libertyville, IL)
- …Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation , and Validation ... computer system validations. You will report to the Quality Validation Manager . How you will contribute: + **Quality Systems /Document Control:** Owns… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …+ 5+ years of experience in Equipment/Facilities/Utilities Qualification experience. + 2+ Computer System Validation (CSV) experience in the pharmaceutical ... **Senior Validation Specialist** with guidance from the Validation Manager , defines and implements procedures and...procedures and processes to assure that Catalent facilities, equipment, computer , and supporting systems are fit for… more
- Takeda Pharmaceuticals (Libertyville, IL)
- …focus on disciplines related to equipment, cleaning, process, control system and computer system validation . **How you will contribute:** + Experience ... Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation , and Validation… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …protocols and reports meet LOTTE BIOLOGICS standards. Reporting to the Senior Manager , Validation Services, you will manage and coordinate installation, ... test plans, and regulatory guidelines. + Proficiency in troubleshooting equipment and systems during validation activities. + Ability to manage multiple… more
