- Abbott (Lake Forest, IL)
- …ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer ... Specialist** **Key Responsibilities also include:** + Effectively assess regulatory and validation requirements for computer systems within organization +… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Boehringer Ingelheim (St. Joseph, MO)
- …of validation of biopharmaceutical processes, equipment, utilities, facilities, cleaning validation , and USDA and FDA /EU regulations. + * Excellence in ... comprehension/application of USDA and FDA /EU regulatory requirements for validation /qualification of equipment/process/cleaning...detail. + * This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for… more
- Catalent Pharma Solutions (Harmans, MD)
- **Lead Specialist, QA Validation & Engineering** Catalent Pharma Solutions is looking to hire a **Lead Specialist, QA Validation & Engineering** to support our ... of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
- Abbott (Columbus, OH)
- …and implementation of the CAPA management system + Develop, execute and review FDA validation protocols and related documentation in accordance with procedures ... meet Division standards. **WHAT YOU'LL DO** + As a Validation Engineer, you'll have the chance to create and...current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred.… more
- Actalent (St. Paul, MN)
- …Cleaning Validation program. + Develop, execute, and maintain a robust Computer System Validation program. General: + Develop, update, maintain SOPs and ... metrics to senior management. Compliance & Quality: + Ensure qualification and validation processes comply with regulatory requirements (eg, FDA , OTC monographs)… more
- J&J Family of Companies (Wilson, NC)
- … Computer system Validation in a cGMP pharmaceutical facility working with FDA regulations + Experience in Computer system Validation working with ... of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data… more
- Curia (Rensselaer, NY)
- …validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation ). Expert in cGMP documentation practices. + ... cleaning validation protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer ...Knowledge of regulations FDA , ICH, ISO 9000-3, PIC/S guides to cGMP, GAMP4… more
- Stryker (Menlo Park, CA)
- …looking for an experienced and highly skilled Senior Staff AI Data and Validation Engineer. A successful candidate will be responsible for developing methods and ... of AI/ML models used in medical devices, ensuring compliance with all applicable FDA guidelines and regulations. This role is crucial for maintaining the safety,… more
- Abbott (Casa Grande, AZ)
- …(GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Proficient with ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Validation Engineer - Casa Grande, AZ Nutrition Plant** **Working at Abbott** At… more
- Curia (Albuquerque, NM)
- …and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), environmental ... mapping and use of Kaye Validator + Experience with FDA and EU regulations for pharmaceuticals and validation...form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong… 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 be a ... address the world's biggest health challenges. The Senior QA Validation Engineer for Beckman Coulter Diagnostics is responsible for...for assisting in the sustainment of a robust Master Validation Plan and support of the MVP strategies. This… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key ... Responsibilities** + Supports equipment qualification and validation activities by providing technical impact assessments and developing sound validation … more
- Mentor Technical Group (Caguas, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... and South America. Job Summary: We are seeking a meticulous and experienced Validation Engineer specializing in Serialization to join our team. The ideal candidate… more
- Abbott (San Diego, CA)
- …people in more than 160 countries. **Lead Design Quality Engineer - Software** ** Validation ** **Working at Abbott** At Abbott, you can do work that matters, grow, ... and cancers. As the **Lead Design Quality Engineer - Software Validation ** , you'll reviews documentation for accuracy, clarity, consistency, completeness and… 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...oral and written communications skills. + Knowledge of US FDA Good Manufacturing Practices (21 CFR). + Strong technical… more
- Cognizant (San Francisco, CA)
- …+ Understanding of Pharma 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.… more
Related Job Searches:
Computer,
Computer Validation,
FDA,
FDA Computer System Validation,
FDA Validation,
Validation