About the Position:
Our organisation is seeking a highly skilled CSV Engineer to take on this exciting opportunity. This role involves working with a global leader in medical technology on capital projects based in Cork.
The successful candidate will be responsible for managing qualification of GxP Computerised Systems involved in plant expansion and improvement projects, including Utilities System(s), BMS changes, and installations of packaging & filling equipment.
Key Responsibilities:
* Design, commissioning, qualification, and validation documentation - drafting, reviewing, and approving CSV related elements of documentation as appropriate.
* Coordinate and execute CSV related commissioning, qualification, and validation activities where applicable, including preparing of validation master plans and executing of DQ, FATs, and SATs.
* Contribute to the scheduling, tracking, reporting, and achieving of project deadlines.
* Provide input into the core aspects of operations, qualification, and validation SOP's.
* Attend departmental and team meetings focused on CSV activities.
* Serve as a CSV representative for internal technical group discussions.
* Understand and apply industry specific compliance standards / regulations to all commissioning / qualification activities.
* Conduct and participate in risk assessments, root cause analysis, and investigations.
* Review, approve, and sign off protocols, reports, project change controls, and deviations.
* Proactively highlight any issues around compliance.
* Participate in internal and external audits and inspections where required.
Requirements:
* Degree level qualification in Science, Engineering or equivalent.
* 10+ years of CSV experience in Pharmaceuticals or Biopharmaceuticals.
* Experience in process automation.
* Understanding and experience in GAMP, GDP, AND cGMP environments.
* Experience with ISA S95 and S88 standards.
* Experience of testing GAMP Category 3, 4 & 5 systems.
* Knowledge of CFR 21 Part11.
* Solid organisational skills including attention to detail and multitasking skills.
Why Choose Us:
Our organisation offers a collaborative work environment with opportunities for professional growth and development. We are committed to delivering high-quality solutions that meet our clients' needs.
What We Offer:
* A competitive salary package
* Ongoing training and development opportunities
* A dynamic and supportive work environment