LSC have a great contract opportunity for a Computer Systems Validation Engineer to join a global Biopharmaceutical company in Carlow. This is a state of the art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia and infectious disease. The site is less than ten years old and has been fitted with the most up to date manufacturing technology and best practices and is truly a “state-of-the-art” facility.
If you want to work on the leading edge of the Biotech industry then this is the opportunity for you. An excellent opportunity for a computer systems validation engineer reporting to the site CSV lead with responsibility for ensuring the development of key AIT quality documents, such as Quality Assurance (QAPs) and test plans, and for ensuing adherence to the QAPs.
o Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy.
o Develop templates for all SDLC deliverables, compliant with compnay standards, to ensure consistent implementation of the validation strategy.
o Work closely with the QAIT function and ensure their requirements are met in all deliverables
o Approver of all AIT SDLC deliverables, ensuring compliance with standards
Education and skills:
o Relevant Computer Science or Engineering degree or equivalent
o 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
o Knowledge of GAMP5.
o Strong experience in one or all of the following systems: DeltaV, PCS7 (or other PLC/SCADA), OSI PI.
Note: Are you currently eligible to work in Ireland? You will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Martin Taggart in LSC on 021 4777 329 to discuss this new role in more detail or apply directly via this advert.