- Merck & Co. (Rahway, NJ)
- … Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Job DescriptionThis Senior Engineer position will provide engineering support to the...and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …initiatives requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role… more
- Formation Bio (New York, NY)
- …that adheres to CI/CD and data governance best practices. Implement data validation and observability frameworks to ensure quality , trust, and reproducibility ... more efficiently.About the PositionWe're looking for a Senior Data Engineer to join the Data Platform team at Formation...AI. While your initial focus will be on building high- quality EHR models for Formation Bio platform, you'll also… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems . ... and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer I will work alongside Process Associates and Process Scientists to… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... practices, to include increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches etc. for optimization… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and related issues Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems , including ... together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything… more
- Merck & Co. (Durham, NC)
- …an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, 12 ... Solving Application (PSA) tool.Support CAPA implementation.Liaison between Mechanical Service Engineer (MSE) and Operations.Review work order documentation.Accountable for work… more
- Merck & Co. (Durham, NC)
- …empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a night shift position, 12 ... duties as requested by the Coach or Mechanical Services Engineer .Routinely provides technical guidance and maintenance/process training to others.Responsible for… more
- Fluor (Greenville, SC)
- …through credibility. Become their trusted partner. * Lead the development of validation master plan development projects. * Leverage existing client relationships to ... Ability to conduct FDA compliance audits. * Experienced with the preparation of validation master plans for new facilities. * Familiar with the preparation and… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior QA Validation Specialist - CSV Systems Engineer is an integral part of ... System Validation efforts. Additionally, the Senior CSV Systems Engineer will provide guidance and expertise...to computer systems validation + Validation experience in a cGMP quality control… more
- PCI Pharma Services (Bedford, NH)
- …Annexure 11 etc.) and guidelines (eg FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or ... shape the future of PCI. **JOB SUMMARY** The CSV Validation Engineer II shall support CSV team...**EXPERIENCE** + At least 3+ years of relevant computer systems validation systems /software/equipment supporting GMP… more
- ManpowerGroup (Redmond, WA)
- Our client, a leader in the semiconductor industry, is seeking a Hardware Design & Validation Engineer - AI Semiconductor Systems to join their team. As a ... which will align successfully in the organization. **Job Title:** Hardware Design & Validation Engineer - AI Semiconductor Systems **Location:** Mountain… more
- General Motors (Pontiac, MI)
- …Engineering, or related field of study and Three (3) years of experience as a Validation Test Engineer , Electrical Engineer , Automotive Engineer , or ... **Job Description** **DUTIES:** Prepare, plan, and conduct validation testing. Report ADV status and creates end...ADV status and creates end of test summaries. Support Quality Processes and collect and Submits Best Practices, Lessons… more
- Takeda Pharmaceuticals (Libertyville, IL)
- …is true to the best of my knowledge. **Job Description** About the role: The Senior Quality Validation Engineer is in the Validation Quality ... and computer system validations. You will report to the Quality Validation Manager. How you will contribute:... Validation Manager. How you will contribute: + ** Quality Systems /Document Control:** Owns Standard Operating Procedures… more
- CACI International (Houston, TX)
- NASA Lunar Gateway Autonomous Control System Verification and Validation (V&V) Software Systems Engineer Job Category: Engineering Time Type: Full time ... for an early to mid-career **Software Systems Engineer ** to perform integrated Verification and Validation ...the flexibility at CACI that allows them to balance quality work and their personal lives. We offer competitive… more
- Amazon (Redmond, WA)
- …collective pursuit of technical excellence. We are seeking an Senior Interdisciplinary Systems Engineer / Technical Program Manager. This role includes direct ... engineering and program management leads to ensure that the systems development meets schedule, cost, and quality ...asylum. Basic Qualifications -5+ years in a technical lead, systems engineer , or technical program management role… more
- Catalent Pharma Solutions (Kansas City, MO)
- ** Quality Engineer , Validation II**...and in compliance to all FDA QSR/cGMP, ISO, and Quality Policies + Provide manufacturing systems expertise, ... Pharma Solutions in Kansas City, MO is hiring a Quality Engineer , Validation II. The...knowledge, and leadership in support of production + Develop systems to identify, analyze, correct, and prevent issues that… more
- GE Vernova (Lubbock, TX)
- **Job Description Summary** Ensure that the North American Systems Validation team has the proper operations support to execute activities related to testing of ... maintained to meet GEV Sourcing and Safety Standards. + Ownership of the Systems Validation equipment including maintenance, calibrations needs and inventory. +… more
- Bristol Myers Squibb (Bothell, WA)
- …Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents are desired. ... regulated GMP manufacturing facility. This position requires a hands-on validation engineer with experience in GMP, an...GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15,… more
- System One (Bellevue, WA)
- System One is seeking highly motivated Senior Safety Verification and Validation Engineer to support our customer in Bellevue Washington. Remote opportunity for ... qualifying candidates. The Senior Safety Verification and Validation Engineer is part of a growing...establish core and reactor SSC functional, performance, safety, and quality requirements as well as support the overall design.… more
