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, benefits, career progression, educational support and much more.
****Automation CSV Engineer 1643
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
* Develop and execute validation strategies for new and existing process automation and computerised systems.
* Support the implementation and validation of DeltaV, Siemens PLC, PI and other automation platforms.
* Prepare and review validation documents including URS, FRS, IQ, OQ, PQ, Validation Plans, Summary Reports and Automation Change Pack (ACP's).
* Develop and execute PV and PQ protocols to support readiness for commercial manufacturing.
* Perform risk assessments, impact assessments, and manage change controls for validated systems.
* Create and maintain traceability matrices ensuring full alignment between requirements, design, and testing.
* Identify, troubleshoot, and resolve validation deviations and test failures in a timely manner.
* Execute commissioning and qualification test cases to verify system functionality and data integrity.
* Support internal audits, inspection readiness, and preparation activities for regulatory licensure (HPRA, EMA, FDA).
* Ensure all validation work complies with 21 CFR Part 11, GAMP 5, EU Annex 11, and site quality standards.
* Collaborate with IT QA to ensure compliance and drive continuous improvement in validation processes.
* Provide validation and regulatory training to team members to support the transition from project phase to operations.
Qualifications
Requirements
**Qualifications & Experience
* 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.
Benefits
Benefits
**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****