Technisch 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