Validation Engineer
PSC Biotech•Columbia, MO
•Onsite
About The Position
The Validation Engineer supports qualification of computerized systems in a regulated life sciences environment. The role supports computerized system lifecycle activities to help ensure systems are appropriately qualified, documented, and maintained in accordance with applicable quality and regulatory requirements. This is a six-month W2 temporary contract based in Columbia, Missouri, with potential for extension. Applicants must be legally authorized to work in the United States; employer-sponsored work authorization and Corp-to-Corp arrangements are not available. Travel may be needed for project assignments and client engagements.
Requirements
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipline, or equivalent relevant experience.
- Previous experience with computerized system validation (CSV) and/or computerized system qualification in a regulated environment.
- Working knowledge of validation lifecycle principles and documentation.
- Understanding of GMP-regulated systems and applicable quality requirements.
- Experience developing, reviewing, and/or executing validation or qualification documentation.
- Ability to identify and document discrepancies and support resolution of validation issues.
- Strong technical writing, documentation, and organizational skills.
- Effective communication skills and ability to collaborate across Quality, Engineering, IT, and other functional groups.
- Ability to manage multiple validation activities and priorities while maintaining attention to detail.
- Must be authorized to work in the United States.
- Willingness and ability to travel as needed for project assignments and client engagements, and to adapt to different locations, cultures, and work environments.
Responsibilities
- Support the qualification and validation of computerized systems.
- Develop, review, and execute computer system validation and qualification documentation.
- Support validation activities throughout the computerized system lifecycle.
- Review system requirements and associated documentation for completeness and compliance with established procedures.
- Develop and execute validation protocols and document results in accordance with approved procedures.
- Identify, document, and support the resolution of discrepancies or deviations encountered during qualification and validation activities.
- Collaborate with Quality, Engineering, IT, system owners, and other stakeholders to coordinate validation activities.
- Support change control and assessment activities for validated computerized systems.
- Maintain accurate and complete validation documentation in accordance with applicable quality requirements.
- Support inspection and audit readiness by ensuring computerized system validation records are complete and traceable.
- Ensure validation activities align with applicable GMP requirements and site procedures.
Benefits
- Medical benefits for W2 temporary roles.
- Sick time benefits for W2 temporary roles.
