- Abbott (Lake Forest, IL)
- …in ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA ... **Key Responsibilities also include:** + Effectively assess regulatory and validation requirements for computer systems ... within organization + Identify and develop all required computer system validation deliverables including… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who...In depth understanding and knowledge of successfully validating a computer system to meet all FDA ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Bristol Myers Squibb (Devens, MA)
- …more: careers.bms.com/working-with-us . **Summary:** We are seeking a highly skilled and motivated Computer System Validation (CSV) Engineer to join our team ... system change controls, deviations, and CAPAs related to computer systems . + Provide training and guidance...current with industry trends and regulatory updates related to computer system validation . **Qualifications:** +… more
- PCI Pharma Services (Bedford, NH)
- …and guidelines (eg FDA , MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical ... with departments inside the organization to maintain and improve computer system validation processes to...skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
- Boehringer Ingelheim (St. Joseph, MO)
- …staff and other departments. + Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow ... effort and is responsible for assuring compliance of validated systems , process, equipment to current cGMP, FDA ,...(VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems , supports feasibility… more
- J&J Family of Companies (Wilson, NC)
- …of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with ... Coordinates and executes training of required personnel on the computer and automation systems validation ...working with FDA regulations + Experience in Computer system Validation working with… more
- Abbott (Columbus, OH)
- …of the CAPA management system + Develop, execute and review FDA validation protocols and related documentation in accordance with procedures and ... and implement the Abbott Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to… more
- Catalent Pharma Solutions (Harmans, MD)
- …This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the ... from the planning stage to completion in a Quality role. + Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex… more
- Curia (Rensselaer, NY)
- …protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer system validation etc. + Review and approve lab ... responsibility is to provide quality review and approval of validation activities associated with changes to existing systems...special projects as directed by management + Perform the computer system periodic reviews in coordination with… more
- Actalent (St. Paul, MN)
- …robust Cleaning Validation program. + Develop, execute, and maintain a robust Computer System Validation program. General: + Develop, update, maintain ... the development, execution, and maintenance of validation systems . + Strong knowledge of cGMP, FDA ...Process Validation requirements. + Working knowledge of Computer System Validation Requirements. +… more
- Curia (Albuquerque, NM)
- …equipment and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), ... validation protocols for processes, equipment, utilities, and test systems . The role also supports new product introductions, equipment...the review of changes made under the Change Control System from a validation perspective + Provide… more
- Abbott (Casa Grande, AZ)
- …**What You'll Work On** + Lead and support Design Qualification processes including; System Impact Assessments (SIA), Project Validation Plan (PVP), Failure Mode ... (GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Proficient with… more
- Bristol Myers Squibb (Devens, MA)
- …Regulatory requirements. + Familiarity with SDLC, CSV deliverables, distributed control systems and automation (GAMP) validation concepts allows this individual ... their personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key Responsibilities**… more
- Mentor Technical Group (Caguas, PR)
- …and quality of serialized products. Key Responsibilities: + Develop and execute validation protocols for serialization equipment, processes, and systems . + ... comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science...records for all validation activities. + Analyze validation test data to determine whether systems … more
- Danaher Corporation (Chaska, MN)
- …+ Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience with Computer System Validation (CSV) and process validation It would ... tools that address the world's biggest health challenges. The Senior QA Validation Engineer for Beckman Coulter Diagnostics is responsible for assisting in the… more
- Abbott (San Diego, CA)
- …Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems . + Assists with supplier ... related field. **Preferred Qualifications** + Masters degree preferred + Knowledgeable of FDA , Quality System Regulations (QSR), Medical Device Directive, ISO… more
- Contract Pharmacal Corp (Hauppauge, NY)
- Junior Engineer; Validation Hauppauge, NY (http://maps.google.com/maps?q=145+Oser+Avenue+Hauppauge+NY+USA+11788) Apply Description Position Summary: The Junior ... Validation Engineer is responsible for performing qualification and engineering...pharmaceutical manufacturing and packaging equipment, facilities, and critical utility systems . Responsibilities:Responsibilities include, but are not limited to: +… more
- Cognizant (San Francisco, CA)
- …value chain, Products/ Platforms used. + Knowledge of FDA regulations for Computer system validation , Medical Device regulations, GAMP 5 + Knowledge ... of Test Automation, Understanding of Gen AI will be a plus. + Experience and proven track record of dealing with IT, business, C level executives. + Well-rounded consultant with the ability to cross-sell, up-sell across all functional areas. + Ability to… more
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