SimoTech require a Lead CSV Engineer, with 10+ years of CSV experience, to work with our client, a global leader in medical technology, on a global capital projects based in Cork. Reporting to the Project Lead/Manager, the successful CSV Engineer will be a key member of the team focused on expansion and transformation of global operations.
The main purpose of this role will be to manage qualification of the GxP Computerised Systems involved in the plant expansion and improvement projects, including but not limited to 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.
* Co-ordinate 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.
* Work closely with the Client QA department and adhere to their requirements.
Qualifications
* 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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Industries
Pharmaceutical Manufacturing
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