Orion Innovation
Computer Systems Validation Engineer
Washington · Contract
Sponsorship not specifiedDetected 22 days ago
SAPERPGMPCommunicationProblem SolvingGxP
About the role
- Orion Innovation is a premier, award-winning, global business and technology services firm.
- The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant client procedures and regulations.
Responsibilities
- Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
- Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
- Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).
- Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity.
Requirements
- Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
Skills
- Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
- Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
- Strong technical and problem-solving skills and the ability to work independently.
- Demonstrated success working in a high-performing, business results-driven environment.
- Understanding of computer system validation.
- Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).
- MES experience Required
- REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Understanding of computer system validation (CSV).
- Education and Experience:
- Strong knowledge on Manufacturing Execution System (MES) validation.
Visa & Work Authorization
- race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, citizenship status, disability status, genetic information, protected veteran status, or any other ch
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This listing is sourced directly from Orion Innovation's careers page and normalized into a canonical job model.