CSV Engineer 1598

5 days ago

Dublin, Ireland SimoTech Full time

+353-21-4834930 Specialists in Life Science Automation and IT Systems

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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 to join our team, supporting the validation for a Drug Product Facility project for our biopharmaceutical client based in Co. Dublin. The successful candidate will have a minimum of 3 years’ experience in developing and validating automation documentation and working closely with SMEs, vendors, & quality teams to ensure compliance with regulations, timelines and operational needs. This is a fully onsite role.

Key Responsibilities

- Responsible for authoring and managing the C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation and summary reports, in collaboration with cross-functional teams.
- Monitor FAT and IOQ execution activities, ensuring alignment with test script intent, identifying & resolving protocol issues and executing CSV related tests on lines and equipment.
- Ensure all automation deliverables comply with regulations and industry best practice standards.
- Maintain consistency and traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ, STQM/RTM and summary reports.
- Identify risks and recommend improvements to the C&Q and automation qualification strategy, documentation quality, and test execution.
- Share key learnings to facilitate effective knowledge transfer for future projects.

Qualifications

- Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar.
- Minimum 3 years’ experience in GMP and validation disciplines, with a strong understanding of pharmaceutical design, build, commissioning, & validation processes, and their alignment with EU and US FDA regulatory requirements.
- Knowledge of regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5.
- Experience working with one or more of the following systems: MES, PI Data Historian, PCS, Lab systems, QBMS, or inspection line control systems.
- Experience working with paperless validation systems (Kneat) would be an advantage.
- Demonstrate excellent interpersonal and communication skills, with strong attention to detail and the ability to work effectively across cross-functional teams.

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.

By submitting my data (CV), I consent to SimoTech collecting and storing my personal data, as outlined in the SimoTech Privacy Statement which I have read.

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