- 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
- 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
- J&J Family of Companies (Danvers, MA)
- …robotics, PLC-controlled systems). + Serve as the **subject matter expert (SME)** for process validation , ensuring alignment with FDA 21 CFR Part 820, ISO 13485, ... automated assembly processes** . + Strong working knowledge of ** FDA , ISO, and GHTF validation requirements** ,...working knowledge of ** FDA , ISO, and GHTF validation requirements** , including IQ/OQ/PQ frameworks. + Proven ability… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and managing validation budget, contracts, and schedules. + Presenting/defending validation data to FDA and other regulatory agencies. + Maintaining ... At Regeneron, we are seeking a Manager, QA (Internal Validation Oversight) to lead a team dedicated to ensuring...a team dedicated to ensuring the integrity of our validation processes. In this role, you will be responsible… more
- VTI Life Sciences (Raleigh, NC)
- …and future site regulatory inspections + SME for presentation of cleaning validation to Regulatory ( FDA ), internal and external auditors. + Identify ... Life Sciences industry. We are looking for 2 Cleaning Validation Engineers to work onsite at our client's pharmaceutical...facility in the Raleigh, NC area. One (1) Cleaning Validation Engineer and One (1) Senior Cleaning 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
- Insight Global (Indianapolis, IN)
- …This engineer will go through a series of CQV (Commission, Qualification, Validation ) within an FDA regulated environment for a pharmaceutical customer. ... Job Description Insight Global is looking for a Validation Engineer to support a large HVAC customer.… 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
- Merck (Rahway, NJ)
- …and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Novo Nordisk (West Lebanon, NH)
- …Ensures change control activities for systems are completed in a manner in compliance with FDA , EU and NN regulations + Support validation of new and existing ... person in this role will also be responsible for validation activities in several areas of pharmaceutical manufacturing including,...are validated in a compliant manner in accordance with FDA , EU and NN requirements + Actively participate on… more
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