SimoTech requires a CSV Engineer to work within a project team with a leading Medical Device company in Cork. Candidates must have a minimum of 3 to 5 years’ experience working within the medical device or life science industry.
- Manage, co-ordinate, develop and execute the validation deliverables for automation projects.
- Support and co-ordinate the qualification and validation processes.
- Preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
- Responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures. This individual will provide compliance leadership, direction and execution in Computer System Validation for new projects.
- Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.
- Participate in required project teams.
- Draft software qualification protocols and support equipment qualification activities.
- Ensure compliance with cGMP, recognized quality standards and regulatory expectation.
Qualifications & Experience
- Third Level Qualification in Automation, IT Systems, Electronic/Mechatronic Engineering.
- Have a minimum of 3 to 5 years’ experience working within the medical device, biotechnology or pharmaceutical industry.
- Working knowledge of Computer System Validation.
- Experience of Medical Device Quality Systems (FDA/ISO) within a regulated environment.
- Documentation development and review.
- High Attention to Detail.
- Pro-active approach to Work.
- Excellent Communication Skills.
- Must be continuous improvement focused.
Only Candidates eligible for work permits for Ireland/EU can be considered for this role.