- Aldevron (Fargo, ND)
- …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 ... and will be responsible for representing the Analytical Method Validation team as a subject matter expert (SME) on analytical test method validation , test method… more
- Aldevron (Fargo, ND)
- …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
- Beckman Coulter Diagnostics (Miami, FL)
- …tools that address the world's biggest health challenges. The Senior QA Validation Engineer for Beckman Coulter Diagnostics is responsible for assisting in the ... sustainment of a robust Master Validation Plan and support of the MVP strategies.This position is part of the Quality Assurance - Validation department located… more
- Cytiva (Miami, FL)
- …including standard operating procedures (SOPs), process flows, and validation reports.Design, test, and implement new manufacturing processes, equipment, ... and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute to audits and inspections as necessary.Who… more
- Aldevron (Miami, FL)
- …required,Experience with labeling equipment qualification and labeling process validation preferred.Bachelor's Degree required; life science related field, ... Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).Strong foundational knowledge in FDA and EU regulations specific to labels and labeling such as… 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...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. Louis, MO)
- …with written validations in consumer goods or manufacturing. + Extensive knowledge of FDA process validation and product manufacturing. + Ability to articulate ... Validation Process Engineer Job Description We are seeking...product. The position requires revisions to ensure compliance with FDA regulations following a recent customer audit. The engineer… 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
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