LSC have a great contract opportunity for a CSV Engineer to join a leading biotech company based in Cork.
If you have 1+ year of experience in the medical device, pharmaceutical or related industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Lead validation activities for DeltaV, MES, and QBAS systems, ensuring GMP compliance during system intervention
- Collaborate with cross-functional teams to implement and maintain Computer System Validation processes including 21 CFR Part 11 and Annex 11 assessments, Business Criticality, and GAMP evaluations.
- Assist in developing and executing validation protocols for various software systems
- Contribute to the creation and maintenance of validation documentation
- Support the team in ensuring compliance with industry regulations and standards
- Participate in continuous improvement initiatives for CSV processes
ABOUT YOU - ARE YOUR SKILLS A MATCH?
Essential:
- 1-2 years of experience in a CSV-related role within the pharmaceutical or life sciences industry
- Bachelor's degree in computer science, Engineering, or a related field
- Familiarity with GxP regulations and industry standards
- Strong analytical and problem-solving skills
- Excellent communication and teamwork abilities
- Attention to detail and a commitment to quality
Please note: Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Paul O'Driscoll on 021 4777 329 if you have any more questions about this opportunity!
