- Aldevron (Miami, FL)
- …for vital new discoveries worldwide. You will be a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation . ... You will assist in representing the Analytical Method Validation team in matters related to analytical test method..., test method transfer, and method development.Foundational knowledge of FDA , EU, and ICH regulations related to test method… more
- Cepheid (Miami, FL)
- …development, specially design control and risk management activities in accordance with FDA and ISO regulations. This position is also responsible to apply ... guidance for Market Specification, Functional Specification, Design Verification, Design Validation , Test Method Validation , Risk Assessments, and Design… 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
- Medtronic (Villalba, PR)
- …methods to ensure continued compliance and quality. + Knowledgeable in aligning Process Validation activities with industry guidelines such as FDA 's Process ... unique opportunity to contribute to meaningful projects, including computer system validation , process validation , data analysis, FACTORY works configurations… 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
- 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
- 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 4 Location: Onsite in Littleton, CO...efforts + Collaborate across functions to maintain compliance with FDA , ISO 13485, and GMP requirements Requirements: + Minimum… more
- Actalent (Lakewood, CO)
- …the medical device industry. + Proficiency in equipment qualification (IQ/OQ/PQ) and process validation . + Strong knowledge of FDA regulations and GMP. + ... Job Title: Validation Engineer Job Description The Validation ...develop test and measurement methods. + Ensure adherence to FDA regulations and Good Manufacturing Practices (GMP). + Collaborate… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …solutions (eg Syncade, Rockwell, ProPack Data, Werum PAS-X) + Knowledgeable in FDA validation requirements preferred, including: User Requirement and Design ... Specs, Business Process Procedures, Design Reviews, Requirements gathering + Experience with SDLC (Waterfall/Agile) + Experience developing user requirements, functional specification documents and test scripts for MES projects + Demonstrate understanding of… 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
- 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
