Computer Systems Validation Engineer

Position: CSV Engineer

At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

Job Description:

We are currently expanding our team and are looking for a CSV Engineer to support projects on site with a client.

In summary, you will be responsible for managing all computer systems validation activities including, but not limited to, drafting, reviewing, and approving all CSV-related activities, as well as conducting deviation investigations, and working alongside the teams that provide QA oversight to ensure consistent compliance of cGMP standards.

Key Responsibilities:

• Support validation activities for projects including PLC network, system and controller upgrades, PCS upgrades, MES implementation, and laboratory equipment installations (e.g., bioreactors, particle monitoring systems).
• Collaborate with subject matter experts (SMEs) to define validation strategies and testing requirements.
• Investigate, document, and resolve deviations/exceptions in collaboration with SMEs, testers, and Quality teams.
• Prepare and review CSV lifecycle documentation including test plans, test reports, validation plans/reports, traceability matrices, data integrity assessments, and validation document lists.
• Maintain and update system design specifications in line with project and validation requirements.
• Provide training and guidance to new users and test executors on CSV processes, testing procedures, and exception handling.
• Drive continuous improvement initiatives, including enhancing validation templates and processes to improve efficiency.

Requirements:

• Degree in Science or Engineering or any other related qualifications.
• Familiar with government code of practice, regulations, current Good Manufacturing Practice (cGMP), Good Documentation Practice (GDP).
• At least 3-4 years of experience in to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

What's In It for You

• Exposure to the major Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

What's Next

If you are interested in applying for this position, please send an email to [Confidential Information].

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation, or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.