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CSV Engineer 1533
Cork
About SimoTech
SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
Why SimoTech
What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
CSV Engineer 1533
SimoTech has an opportunity for a Computer Systems Validation Engineer to join our team, supporting our client in a state-of-the-art biotechnology site in Cork. The successful candidate will have 2+ years’ experience in a similar role in the life sciences industry and will support automation projects.
Key Responsibilities
- Assist in creating and executing validation strategies for new and existing automation computerised systems.
- Support the implementation and validation of DeltaV DCS.
- Help write and review key validation documents, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and Validation Plans.
- Carry out risk assessments on validation activities.
- Identify and resolve validation test deviations or failures.
- Support the creation of traceability matrices and change controls for validated systems.
- Preparing validation summary reports.
- Provide support during audits and inspections from a validation perspective.
- Ensure work is completed in compliance with industry standards and regulations, including 21 CFR Part 11, GAMP5, and EU Annex 11.
- Collaborate with the Quality Assurance team to identify and amend any compliance gaps and to improve validation processes.
Qualifications
- Bachelor’s Degree in Engineering, Information Systems, Computer Science or Life Sciences.
- Minimum of 2 years’ experience as a CSV Engineer, supporting DeltaV automation or labs, in a pharmaceutical environment.
- Familiarity with 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines.
- Working knowledge of risk management practices and tools such as FMEA.
- Strong written and verbal communication skills with the ability to work in a cross-functional team.
- Strong attention to detail, organisational and problem-solving skills.
What SimoTech Can Offer
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capital projects.
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