Parttime Engineer

Our Client are in Belfast is expanding and the Program manager for the Manufacturing Quality group tasked with integration of the QMS is looking for a Senior Manufacturing Validation consultant, Manufacturing Validation Consultant. Full time onsite (occasional hybrid) Plan and execute the re-qualification of existing manufacturing equipment (IQ, OQ, PQ) to meet corporate and regulatory standards. Align local manufacturing Standard Operating Procedures (SOPs) with the newly adopted QMS requirements. [Perform rigorous risk assessments (e.g., FMEA) on transitioning production lines to mitigate risks during the system switchover. Validate manual assembly steps Bachelor’s degree in Engineering (Manufacturing, Mechanical, , or Biomedical) or a related scientific discipline. ~8+ years of direct experience in manufacturing validation and quality assurance within a highly regulated industry ~ trong, working knowledge of regulatory guidelines and standards like FDA 21 CFR Part 11 & ISO13485 ~ PLEASE NOTE THIS IS A CONTRACT ROLE