- 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
- Merck & Co. (Durham, NC)
- …multi-stage refrigeration systems ).Good oral and written communication skillsProficiency in computer systems and applications including but not limited to:- ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling… more
- Eisai, Inc (Nutley, NJ)
- …with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively ... and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a… 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 ... Quality Control, IT and Validation organizations to support SaaS enterprise computer systems validation of Gene therapy like but not limited to… 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 ... goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams.… more
- BeOne Medicines (San Carlos, CA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Senior Manager , Systems Validation in San Carlos, CA: **Job Duties:** Manage the entire GxP change control ... requirements from business stakeholders to establish intended use of computerized systems . Collaborate with project stakeholders to author validation … 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
- Curia (Rensselaer, NY)
- …of five (5) years' relevant experience working in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP ... team. This role is responsible for supporting Quality Management Systems and Computer System Validation ...date trainings + Other duties as assigned by QA manager and/or QA director Education and Experience: + Bachelor's… 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
- CACI International (Houston, TX)
- …integrated Verification and Validation (V&V) of the on-board, autonomous Vehicle Systems Manager (VSM) and Autonomous Systems Management Architecture ... NASA Lunar Gateway Autonomous Control System Verification and Validation (V&V) Software Systems Engineer Job...USG facilities. + BS in Electrical, Mechanical, Aerospace, Software, Computer or Systems Engineering, Computer … more
- Novo Nordisk (Bloomington, IN)
- … strategy and mentor engineers/senior engineers on execution. Relationships Reports to Manager , Validation . Essential Functions + Equipment Validation + ... and approve deviations relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer system validation… more
- PCI Pharma Services (Rockford, IL)
- …instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . ** Computer Validation Focus:** _Associate's Degree in ... meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager . Investigate validation... computer tasks and have some experience with computer systems considered to have an impact… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …formulation. The **Senior Validation Specialist** with guidance from the Validation Manager , defines and implements procedures and processes to assure ... that Catalent facilities, equipment, computer , and supporting systems are fit for...Qualification. + Assuring cGMP compliance related to Qualification and Validation of equipment/ systems , utilities, and facilities throughout… more
- System One (Bellevue, WA)
- …Design Basis Accident (DBA) Without Radionuclide Release * Nuclear safety analysis computer code assessment, verification and validation The Senior Safety ... (EM) following the guidance in NRC's RG1.203. * Perform and coordinate safety computer code verification and validation test programs, including SETs and IETs… more
- Takeda Pharmaceuticals (Libertyville, IL)
- … system validations. You will report to the Quality Validation Manager . How you will contribute: + **Quality Systems /Document Control:** Owns Standard ... 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
- 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
- AbbVie (North Chicago, IL)
- …and overall approval of validation tasks. Under the direction of the Validation Section Manager , will participate in the implementation of the Validation ... of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (eg Computer , Equipment, Cleaning, Process, etc.) preferred… more
