Csv engineer

CSV (Computer System Validation) Engineer – Pharma IT Systems
Location:
Limerick (Hybrid)
About the Role:
We are seeking a dynamic and detail-oriented CSV Engineer to join our pharmaceutical IT team. You will be responsible for Computer System Validation (CSV) activities primarily for Manufacturing Execution Systems (MES) such as Syncade and Tulip, as well as various ancillary IT systems supporting GMP operations.
Key Responsibilities:

Lead and execute CSV projects for IT systems, with primary focus on MES platforms (Syncade, Tulip).
Author and review validation documentation (e.g., Validation Plans, URS, FRS, IQ, OQ, PQ, Traceability Matrix, Risk Assessments).
Ensure all validation activities align with GxP, FDA 21 CFR Part 11, EU Annex 11, and other relevant regulatory requirements.
Work closely with system owners, IT, QA, and project teams to manage the end-to-end validation lifecycle.
Investigate and assess changes, deviations, and incidents relevant to IT systems from a CSV perspective.
Support audits and inspections by providing subject matter expertise on CSV activities and documentation.
Track and report CSV status and activities to project teams and management.
Participate in continuous improvement of CSV workflows and procedures.

Desired Skills & Qualifications:

Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field.
3+ years’ experience with CSV in the pharmaceutical or life sciences industry.
Hands‑on experience validating MES platforms (especially Emerson Syncade, Tulip).
Strong familiarity with GMP, GAMP5, and regulatory requirements for computerized systems.
Proficient in the preparation and execution of CSV documentation.
Excellent communication, organizational, and teamwork skills.
Experience with other pharma IT systems (e.g., LIMS, QMS) is a plus.

Why Join Us?

Opportunity to work on leading-edge MES and pharma IT projects
Supportive and collaborative international team
Exposure to a regulated, innovative industry

We look forward to hearing from you!
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