CSV Specialist

CSV Specialist - Wicklow, Ireland - 12 Month Contract 

Are you based in Ireland and looking for your next pharmaceutical contract role? Our client, a well-established global organisation in the life sciences sector, is hiring for a CSV Specialist to join their newly established team. This role lets you contribute to impactful projects that drive innovation in healthcare and animal wellbeing, while gaining experience with a company known for its scientific excellence and global reach.

What you’ll do:

• Support preparation, review, and approval of Site Validation Master Plans (VMPs) and supporting plans/strategies for: Facilities, Equipment, Utilities, Laboratory Methods, Process, and Computerized Systems.
• Define and maintain site CSV frameworks including CSV Plan, templates, SOP/work instruction inputs, and project validation deliverables structure.
• Ensure validation approaches follow a risk-based lifecycle model (e.g., V-model) and are scalable for project scope and system criticality.
• Provide CSV leadership/support to project teams to ensure commissioning, qualification, and validation activities for IT/OT infrastructure and manufacturing control systems are executed compliantly.

What you’ll need:

• BEng or equivalent experience in life science or engineering; knowledge in validation and quality compliance (cGMP//ICH/FDA/USP/EU policies/guidelines).
• In depth knowledge of FDA 21CFR pt11 and ANNEX 11 regulatory requirements.
• Experience in ISA95 and ISA88 standards from a Qualification perspective.
• Extensive Validation experience in Computer System Validation and Engineering/Commissioning experience.
• Validation experience with DCS/SCADA control systems and associated equipment, support equipment, utility systems, computerised systems/automation, periodic reviews, cleaning and process validation.

Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!
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