- Merck & Co. (Rahway, NJ)
- …testing.Provide independent Quality Assurance oversight for the implementation of new computerized systems , change control involved with existing computerized ... for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and... systems as well as the retirement of computerized systems in the Clinical Supply domain.Develop… more
- Merck & Co. (Durham, NC)
- …process equipmentMaintain utility equipment by developing/installing new equipment, completing validation protocols, documenting work using a computerized ... Job DescriptionWe are seeking a Growth and Improvement minded- Senior Maintenance Technician - HVAC & Refrigeration that can help drive our Strategic Operating… more
- Bristol Myers Squibb (Bothell, WA)
- …with Business Owners, Technical Owners and Quality to create, manage, and improve computerized systems validation deliverables for electronic systems ... and experience with application of guidelines and regulations related to control of computerized systems , electronic records and electronic signatures + 5+ years… more
- United Therapeutics (Silver Spring, MD)
- …For the _Senior Validation , Engineer_ level: Working knowledge of target systems , including computerized information systems , manufacturing control ... and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …operations automation qualification with Honeywell, Delta V, and PCL-based systems + Computerized systems validation + Cleaning validation + ... of my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Validation Engineer where you will support site projects, technical transfers,… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …operations automation qualification with Honeywell, Delta V, and PCL-based systems + Computerized systems validation + Cleaning validation + ... and aseptic processing validation . + Process and utility systems validation , temperature mapping, manufacturing equipment commissioning and qualification.… more
- Charles River Laboratories (Memphis, TN)
- Senior Validation Engineer Req ID #:... systems and equipment that may also incorporate computerized systems . + Advanced understanding and experience ... Sr. Engineer will have the experience to be functional lead responsible for Validation (CQV) deliverables for the facility, utilities, systems and equipment… more
- WuXi AppTec (Philadelphia, PA)
- …and approval of equipment/software validations (including Computerized Laboratory Systems ), System Life Cycle Documentation ( Validation Plans, Design ... Specifications, Requirements Specifications, etc.), Change Controls, Decommissioning Reports, etc., in accordance with 21 CFR Part 11 and GAMP5. Monitors equipment/software processes for adherence to established procedures/regulatory compliance. Provides… more
- Merck (Rahway, NJ)
- …+ Provide independent Quality Assurance oversight for the implementation of new computerized systems , change control involved with existing computerized ... for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and... systems as well as the retirement of computerized systems in the Clinical Supply domain.… more
- Amgen (Holly Springs, NC)
- … and change control methodology. + Hands-on experience with computerized systems including troubleshooting, reliability, and performance improvements. ... best work alongside other innovative, driven professionals in this meaningful role. ** Senior Manufacturing Systems Engineer** **Live** **What you will do** Let's… more
- AbbVie (North Chicago, IL)
- …processes & technology usage. + Provide strategic input on the analysis of new computerized systems & software used for clinical trial data collection, quality ... assignment, & development opportunities for staff within responsibility. + Complete the validation of electronic systems , software & programs applied internally… more
- Bristol Myers Squibb (Phoenix, AZ)
- …deliverables during the design, delivery, commissioning of good manufacturing practices (GMP) computerized systems at the Phoenix site. + Provides support to ... protocols and/or test scripts for systems as required. Routine support for GMP computerized systems at the Phoenix Site + Performs routine user and system… more
- Catalent Pharma Solutions (Bloomington, IN)
- …automated systems , including major capital projects and continuous improvement of systems + Review and approve changes to computerized automation production ... ** Senior Engineer - Process Engineering** Catalent is a...**The Role:** + Support the multi-use facility, including HVAC systems and bio-containment systems + Support selection… more
- BeiGene (San Mateo, CA)
- …quality and regulatory business processes. + Direct hands-on experience implementing GxP computerized systems and maintaining validated state. + Strong process ... of implementation plans/qualification tests + participate in the authoring of computerized system validation documentation Management of system operations in… more
- WuXi AppTec (Philadelphia, PA)
- …streamline, architecture upgrade, recipe delivery, and testing coordination. + Follow the Computerized Systems Validation process and Software Lifecycle ... 39,000 employees with 32 facilities in 9 countries. The Senior IT Project Manager (MES) is responsible for leading...process flow and present it to customers Testing and Validation of MES. + Partner with the functional groups… more
- Jacobs (Cincinnati, OH)
- …and Qualification o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems o ASTM E2500 Standard Guide for Specification, Design, and ... we give our best and know that we're making a difference. As a Senior Commissioning, Qualification, and Validation (CQV) Engineer, you'll join our collaborative… more
- Fresenius Medical Center (Lexington, MA)
- …team members when heightened access rights are needed to access servers/background of systems + Support with system testing during validation of software ... server systems and technical architecture + Experience with software validation documentation within GxP environment and release process + Experience with QMS… more
- Merck (Durham, NC)
- …equipment + Maintain utility equipment by developing/installing new equipment, completing validation protocols, documenting work using a computerized maintenance ... **Job Description** We are seeking a Growth and Improvement minded Senior Maintenance Technician | HVAC & Refrigeration that can help drive our Strategic Operating… more
- Bristol Myers Squibb (Seattle, WA)
- …(Process Development scientists, Manufacturing Sciences engineers, Manufacturing operators, Computerized System Validation specialists) to translate requirements ... and the ability to help patients are incredible. We are seeking a ** Senior Principal Process Control Engineer** to design and develop novel process control… more
- Jacobs (Conshohocken, PA)
- …and Qualification o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems o ASTM E2500 Standard Guide for Specification, Design, and ... know that we're making a difference. As a Commissioning, Qualification, and Validation (CQV) Project Manager, you'll join our collaborative team providing CQV… more
