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, benefits, career progression, educational support and much more.
SimoTech has an opportunity for a Computer Systems Validation Engineer to join our team, supporting our client at a state‑of‑the‑art biotechnology site in Cork. The successful candidate will have 3+ years’ experience in a similar role within the life sciences industry and will support automation projects with a focus on validation activities. This role involves validation support for automation systems and requires strong skills in non‑conformance investigation and technical writing.
Key Responsibilities
Assist in creating and executing validation strategies for new and existing automation computer‑is‑ded systems.
Support the development and execution of CSV strategies for new and existing automated and computer‑is‑ded systems in a GMP environment.
Support the implementation and validation of DeltaV DCS and associated automation systems used in life‑sciences manufacturing.
Prepare and review validation documentation, including URS, FRS, Validation Plans, IQ, OQ, PQ, traceability matrices, and Validation Summary Reports.
Perform risk‑based validation activities in line with GAMP 5 principles and regulatory expectations.
Execute validation testing, identify and manage deviations, and support investigations and corrective actions.
Support change control activities and assess validation impact for system changes.
Provide validation support during internal and external audits and inspections.
Ensure compliance with 21 CFR Part 11, EU Annex 11, and site quality procedures.
Work collaboratively with Quality Assurance, Automation, Engineering, and IT to maintain validation compliance and continuously improve CSV processes.
Qualifications & Experience
Bachelor’s Degree in Engineering, Information Systems, Computer Science or Life Sciences.
Minimum of 3 years’ experience as a CSV Engineer, supporting DeltaV automation in a pharmaceutical environment.
Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5 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‑disciplinary environment.
Opportunity to work with large corporate clients.
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