Orion Innovation
Computer Systems Validation Engineer
WashingtonmidAdded yesterday
About this role
Orion Innovation is seeking a Computer Systems Validation Engineer to oversee validation activities for GxP electronic systems and applications, ensuring compliance throughout the validation lifecycle. The role involves collaborating with various stakeholders to document systems and execute validation tasks in accordance with established procedures.
What you'll do
- Author and review validation documentation
- Assist in test execution and document failures
- Develop requirements for computerized systems
- Ensure alignment with internal procedures
- Handle other related duties as assigned
What they're looking for
- Experience with Manufacturing Execution Systems (MES)
- Strong communication skills
- Knowledge of cGMP and GxP regulations
- Familiarity with IT service management platforms (e.g., ServiceNow)
- Understanding of computer system validation (CSV)
- Technical and problem-solving abilities
- Knowledge of pharmaceutical and laboratory systems
- Experience with Business Quality Management Systems (e.g., Veeva)
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