CSV Engineer - Ireland, Cork - 12 Months Initial Contract
Our client is undergoing major expansion, supported by substantial investment aimed at increasing its overall manufacturing capacity in the medical device sector.
Recent upgrades include the development of new, state-of-the-art facilities, advanced automation systems, and additional infrastructure enhancements designed to strengthen operational resilience and meet growing global healthcare demands.
With a long-established presence and a highly skilled workforce, the site requires the role of a CSV Engineer to join their project based in Cork.
What you'll do
Guide, develop and lead the overall CSV approach and validation methodology outlined in the CSV program ensuring it is performed as per relevant site procedures and applicable regulations.
Provide guidance to resolve issues as they arise ensuring solutions and decision making is managed in a collaborative manner.
Manage stakeholders at monthly reporting meetings.
Generate and approve all key documentation, providing guidance to ensure team alignment to meet project document schedule.
Work closely with relevant engineering disciplines and vendors of equipment to ensure deliverables meet qualification requirements.
What you'll need
A strong knowledge of DCS Automation systems and GXP systems.
Previous knowledge with DCS Automation (Rockwell PlantPax 5.0), BMS (IQ Vision), HVAC, WFI (Veolia), autoclaves (Fedagari) and Optima filling lines.
Relevant qualification (degree) and/or relevant experience of 10 years in biotech/pharmaceutical industry qualifying Automation GXP systems.
Previous experience leading an Automation & CSV team, managing the team workloads ensuring that all CSV deliverables are achieved as per project schedule.
Previous experience of senior Automation & CSV roles held with a solution driven mindset.
Significant project lifecycle experience in Automation & CSV validation of GXP systems adopting a risk-based approach.
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