- Robert Half Technology (New Haven, CT)
- …GxP regulations * Manage the entire System Development Life Cycle (SDLC) of computer systems , ensuring validation is integrated at each stage * Create ... skills in GxP and GxP FDA. * Proficiency in handling Computer Systems and System Validation . * Experience in Compliance Risk management related to IT … more
- Catalent Pharma Solutions (Harmans, MD)
- ** Computer Systems Validation Engineer**...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...Author and Review of Validation Deliverables - Validation Master Plan (VMP), System Impact Assessment,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Approach depending on process and technical risks Proactive and consultative engagement of the Computer System Validation role within agile projects 2. Guide ... framework by conducting self-developed, process adapted training. Give active feedback into the Computer System Validation (CSV, Management System Owner… more
- PCI Pharma Services (Bedford, NH)
- …/software/equipment. Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, ... skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems...(eg FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation … more
- Astrix Technology (St. Joseph, MO)
- ** Computer System Validation Engineer** Engineering Saint Joseph, MO, US Pay Rate Low: 80.00 | Pay Rate High: 85.00 + Added - 09/01/2025 Apply for Job We are ... seeking a Senior Computer System Validation (CSV) Engineer...Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports. + Validate GMP lab systems… more
- J&J Family of Companies (Danvers, MA)
- Johnson & Johnson Abiomed is recruiting for a Staff Computer System Validation (CSV) Engineer. This position can be based at any Abiomed site in the United ... validation plans for new and existing GxP computer systems and digital solutions. + Support...six (4-6) years of related experience + Experience in computer system validation in MedTech… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... will work with lab & process automation, large corporate systems , small biotech systems , across all functions...corporate policies and procedures related to all aspects of computer system validation and applicable… more
- University of Washington (Seattle, WA)
- …of Quality System documentation and standard operating procedures (SOPs) for computer system validation . + Develop and standardize validation ... Department of Laboratory Medicine and Pathology** has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** +… more
- PCI Pharma Services (Rockford, IL)
- …calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . + Computer Validation Focus: Ability to ... validation plans for new customer / product / system project launch and maintains existing validated processes /... computer tasks and have some experience with computer systems considered to have an impact… more
- Fujifilm (College Station, TX)
- … cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design fundamentals, ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Boehringer Ingelheim (Athens, GA)
- …staff and other departments. + Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow ... Master Plan (VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems , supports feasibility studies, equipment… more
- Sanofi Group (Framingham, MA)
- …supporting the CSV program and computer systems + **Strong Computer System Validation knowledge** **SPECIAL WORKING CONDITIONS:** + Occasional ... and bring hope to patients and their families. The Computer Systems Validation (CSV) team...be responsible for providing technical guidance related to Sanofi computer system validation directives aligned… more
- Charles River Laboratories (Newark, DE)
- …or related field. **Experience:** ⦁ Minimum of 1-2 years experience in a computer system validation or software testing within pharmaceutical, biotechnology, ... business workflows. ⦁ Become a Subject Matter Expert (SME) in relevant computerized system validation technologies, including the corporate Master Validation … more
- Mentor Technical Group (Gurabo, PR)
- …Belt). + Project management and/or project owner experience. + Process and CSV validation knowledge. Mentor Technical Group es un empleador que ofrece igualdad de ... oportunidades y todos los solicitantes calificados recibiran consideracion para el empleo sin importar raza, color, religion, sexo, orientacion sexual, identidad de genero, informacion genetica, origen nacional, estado de veterano protegido, estado de… more
- Fujifilm (College Station, TX)
- …Life Sciences, Engineering, or similar discipline with 7+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or ... Plans (VPPs), System Impact Assessment (SIAs) and drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as Facilities, Utilities and Equipment, Cleaning (CIP/COP), Sterilization (Autoclaves & SIPs), Computer System Validation (PCS/PAS, BMS, CMS, DeltaV, OSI ... Demonstrate basic experience in validation disciplines (equipment, facilities, critical systems , computer , cleaning, process to also include HVAC and… more
- Bayer (Berkeley, CA)
- …utilities, facilities, SIP, temperature mapping validation experience is desired; + Computer systems validation experience is desired; + Prior experience ... to support assessment of critical issues and impact of validation on different elements of quality system ...approaches to validation ; + Ability to set validation strategy for complex systems and execute… more
- Actalent (Irvine, CA)
- … protocols + Pharmaceutical + Validation testing + Equipment validation + Computer system validation + Technical writing + Process validation + ... and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic… more
- Curia (Burlington, MA)
- … validation and revalidation protocols for processes, equipment, utility, and computer software validation . Work with Engineering and Facilities personnel to ... ensure proper installation and operation of systems prior to and post- validation . Provide technical...for new processes and equipment, in conjunction with the system owners; * Support department projects by assisting the… more
- Integra LifeSciences (Plainsboro, NJ)
- …: * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * Test Method Validation * Temperature ... outcomes and set new standards of care. Qualified candidates for this **Senior Validation Engineer** must be experienced in one or more of the following areas… more