- 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...concerns in a timely manner + Comply to all FDA policies and standards + Use M-Files to house… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …Validation experience is also accepted + Requires basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. ... Position Summary & Responsibilities: Develop, support and implement basic validation initiatives as defined in site goals and objectives. Responsible for the… more
- Actalent (St. Paul, MN)
- …metrics to senior management. Compliance & Quality: + Ensure qualification and validation processes comply with regulatory requirements (eg, FDA , OTC monographs) ... , Quality engineering, regulatory, risk assessment, equipment qualification, performance qualification, validation , gmp, cgmp, fda , system validation Top… more
- Unither Pharmaceuticals (Rochester, NY)
- …change and adapt project scope creep and change in timelines. Understanding of FDA requirements for validation . The ability to analyze and interpret data. ... Computer Systems Validation Specialist Who we are? We are a...mitigation methods. Develops, writes, and executes qualification protocols ensuring FDA 21 CFR part 11 and Annex 11 compliance… 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 of regulated biological articles.… more
- Bristol Myers Squibb (Devens, MA)
- …to work and manage within a regulatory environment. + Knowledge of regulatory validation requirements including FDA , EMA and all other Worldwide Regulatory ... personal lives. Read more: careers.bms.com/working-with-us . **Position:** Manager, Cleaning Validation , Validation Engineering **Location** : Devens, MA… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and sterilization processes in Regeneron's Rensselaer facility. You will participate and defend validation data in FDA and other regulatory inspections. In this ... validation budget, contracts, and schedules. + Presenting/defending validation data to FDA and other regulatory agencies. + Maintaining validation … more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …work as a means to influence collaborators and provide proactive solutions + Presents/defends validation data to FDA and other regulatory agencies + Ensures that ... We are currently looking to fill a Director, QA Validation (Drug Product) position. This position leads department responsible for Drug Product Qualification/… more
- Abbott (Lake Forest, IL)
- …CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer System Assurance + ... mothers, female executives, and scientists. **The Opportunity** This position **Software Validation and Cybersecurity Specialist** works out of our Lake Forest, IL… more
- System One (Littleton, CO)
- …industry + Demonstrated experience with IQ/OQ/PQ, process validation , and test method validation + Working knowledge of FDA regulations, ISO 13485, GMP, and ... Job Title: Validation Engineer Location: Lakewood, CO (Onsite - relocation...efforts + Collaborate across functions to maintain compliance with FDA , ISO 13485, and GMP requirements Requirements: + Minimum… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory ... We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized...11, GAMP 5, and Annex 11. **As a Senior Validation Specialist, a typical day might include:** + Planning… more
- Emerson (Blue Bell, PA)
- …+ Experience with regulatory/compliance documentation and procedures + Knowledgeable in FDA validation requirements preferred, including User Requirement and ... Design Specs, Business Process Procedures, Design Reviews, Requirements gathering + Experience with GAMP5 + Knowledge of PMI Project Management framework. + Knowledge of MES systems **Our Culture & Commitment to You** At Emerson, we prioritize a workplace… more
- J&J Family of Companies (Irvine, CA)
- …all aspects of medical device product development, including design, verification and validation , FDA submission, and design transfer into manufacturing. + ... projects, such as technical reports, work instructions and method and process validation . + Leads basic engineering operations, and complex scientific evaluation on… more
- ManpowerGroup (Camarillo, CA)
- …ability to use CAD software as needed. + Good understanding of GMP and FDA process/equipment validation , and SOP writing. + Proven ability to manage high-value ... + Manage installation, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), validation , and other key activities, rapidly addressing any issues. + Organize… more
- Corza Medical (Parsippany, NJ)
- …financial regulations, reporting standards, and supply chain best practices. + Ensure FDA software validation compliance for ERP-related processes in regulated ... environments. + Documents processes or set of procedures for user instructions, standard operating procedures, technical archives or audits. + Managing outside consultants as well as managing their time. **What you will need** + Bachelor's degree in… more
- Globus Medical, Inc. (Audubon, PA)
- …idea/concept through design, prototyping, development testing, design verification and validation , manufacturing, FDA approvals, product introduction and ... specifications for new product development + Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project + Manages all aspects… more
- Globus Medical, Inc. (Audubon, PA)
- …idea/concept through design, prototyping, development testing, design verification and validation , manufacturing, FDA approvals, product introduction and post ... specifications for new product development + Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project + Manages all aspects… more
- Globus Medical, Inc. (Audubon, PA)
- …idea/concept through design, prototyping, development testing, design verification and validation , manufacturing, FDA approvals, product introduction and post ... specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all… more
- Sanofi Group (Cambridge, MA)
- …with industry's best practices in bioanalytical assay development and regulatory expectations ( FDA and EMA) for validation of PK, immunogenicity and biomarker ... + Serve as system administrator for laboratory software and facilitate the validation and implementation of quality systems in the laboratory. + Program, maintain… more
- Bio-Techne (Wallingford, CT)
- …improvements. + Knowledge of quality management systems, regulatory compliance (ISO 13485, FDA ), and experience in validation processes. + Strong analytical ... and methodologies, enhancing product quality and manufacturing efficiency. + Lead validation protocols for new equipment and processes in compliance with ISO… more