CSV Delta V Engineer - #1102435

We are currently expanding our team and are looking for a CSV Delta V 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:

• Provides expertise in performing Computerized Systems Validation.

• Collaborate with validation and tech support teams in other sites to ensure a consistent and cohesive approach.

• Conduct deviation investigations, identification and completion of corrective and preventative actions.

• Supervise contractors, engineers and provide day to day support to operations including, modifications and changes to processes and equipment, and troubleshooting activities.

• Ensure timely completion of all validation related activities including computer system, equipment, utilities, and facility with compliance.

• Perform assessment of vendor documents for CSV deliverables.

• Analyse business trends, and propose solutions to issues that can potentially impact the validation status of GMP equipment.

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 5 years of experience in to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.