- Colgate-Palmolive (Sanford, ME)
- …21 CFR 210 & 211, and experience in working in a regulated industry (ie FDA ) + Working knowledge of SAP, validation software (KNEAT), InBatch or similar ... internal /external networking. Key technical deliverables include; process optimization and validation , technical transfer including SAP item setup and Management of… more
- Medtronic (Fridley, MN)
- …User Requirements and System Design to Code Development, Testing, and Validation , ensuring systems meet both technical specifications and regulatory standards (eg, ... FDA , 21 CFR Part 11). You'll work closely with...with GAMP 5 principles and their application in software validation and documentation is highly desirable. Responsibilities may include… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …in alignment with FDA and QSR standards. + Develop and execute validation plans for service test systems and methods. + AUTOMATION & WORKFLOW IMPROVMENT + ... TestStand, Python, or equivalent frameworks. + Establish test requirements, strategy, and validation approaches for new and existing test methods. + Troubleshoot and… more
- Merck (West Point, PA)
- …of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness: + Lead the cross-functional Device… more
- Bristol Myers Squibb (Summit, NJ)
- …vendors. Experience with technical writing and document development / generation + Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, ... + BS degree or equivalent experience + Minimum 5 years of experience in FDA -regulated industry with at least 2 years of recent hands-on CSV and implementation… more
- J&J Family of Companies (Titusville, NJ)
- …Re-qualification, as well as PQ activities * In partnership with E&PS own Computer Systems Validation , including writing and driving CSV protocols, Functional ... of contact for all technical matters related to Commissioning, Qualification & Validation . The CAR-T (CQV) Lead is responsible for providing compliance expertise,… more
- Abbott (Sylmar, CA)
- …and training to the site engineers for Non-Product Software development and validation , Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure ... Engineering in the completion of system/software requirements and other verification and validation processes. + Create and execute or direct software validation … more
- Abbott (Westfield, IN)
- …+ Manages program compliance with Quality requirements (ie Design Control, Process validation etc.). + Can identify work environment issues (ie OSHA regulations, ... (DOEs). + Assists in start up of new equipment and execution of validation protocols. + Participates in technical design reviews for process equipment and product… more
- Abbott (Alameda, CA)
- …domains: embedded under a disciplined product development process that meets FDA requirements. Work on software design, coding, and validating software, supporting ... verification and validation testing, and ensuring that all product development conforms...Design Control procedures for software development in accordance with FDA guidelines. + At this level, it is expected… more
- Oracle (Augusta, ME)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more