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Senior CSV Systems Engineer
2 months ago
We are seeking a highly skilled Senior CSV Systems Engineer to join our team at Curia. As a key member of our Quality team, you will play a critical role in supporting Quality Management Systems and Computer System Validation efforts.
Key Responsibilities- Provide guidance and expertise on various global and site CSV projects to ensure quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections.
- Collaborate with cross-functional teams to identify required validation deliverables for new systems/software/equipment or changes to existing validated systems/software/equipment.
- Perform gap assessments on vendor-executed protocols to ensure compliance with current regulations.
- Develop and execute CSV change records, CAPAs, and Quality events for CSV projects.
- Act as investigator on any CSV deviations and support site CSV actions resulting from client/regulatory audits.
- Bachelor's degree in Engineer, Life Science, Information Technology, or related field.
- Minimum of seven (7) years' experience working in a cGMP regulated industry specific to computer systems validation.
- Validation experience in a cGMP quality control laboratory or sterile fill finish operations, developing and executing SDLC documents that meet current regulatory and industry expectations.
- Generous benefit options.
- Paid training, vacation, and holidays.
- Career advancement opportunities.
- Education reimbursement.
- 401k program.
- Learning platform.
We are an equal opportunity employer and welcome applications from diverse candidates. Please apply online and do not contact us via email or phone. We are committed to maintaining a safe and healthy work environment and require all employees to adhere to our safety protocols.