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Automation CSV Engineer 1528
Limerick
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.
Automation CSV Engineer 1528
SimoTech require an Automation CSV Engineer to join our team, supporting a biotech manufacturing facility for our multinational biopharma client based in Limerick. You will join a state-of-the-art facility, incorporating new technologies, with a specific focus on operational flexibility, environmental sustainability, and fast track delivery concepts.
The successful candidate will support the validation of computerised systems within the process automation framework, ensuring their compliance with pharmaceutical industry standards and regulations. The ideal candidate will have extensive experience as a CSV Engineer in a pharmaceutical environment. The role offers a hybrid working model.
Key Responsibilities
- Create and execute validation strategies for any new or existing process automation computerised systems.
- Assist with the implementation and validation of systems including DeltaV, Siemens PLC, Pi etc.
- Write and review 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.
- Creation of traceability matrices.
- Change controls and impact assessments for validated systems.
- Create and execute test cases for the verification of system functionality and data integrity.
- Preparation of validation summary reports.
- Provide support for audits and inspections from a validation perspective.
- Ensure all work is completed in compliance with industry standards and regulations including 21 CFR Part 11, GAMP5, and EU Annex 11.
- Provide validation and industry standards & regulations training to relevant team members.
- Work in conjunction 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 5 years’ experience as a CSV Engineer in a pharmaceutical environment.
- Experience supporting process automation systems and manufacturing technologies from a CSV perspective.
- Good knowledge of 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines.
- Hands on experience validating DeltaV and Siemens PLC automated systems.
- 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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