Validation 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) LOA – 18 months -2 years Start – end of June Plan and execute the re-qualification of existing manufacturing equipment (IQ, OQ, PQ) to meet corporate and regulatory standards. Assess and update Process Validation Master Plans (PVMP) to reflect updated Align local manufacturing Standard Operating Procedures (SOPs) with the newly adopted QMS requirements. (1) Perform rigorous risk assessments (e.g., FMEA) on transitioning production lines to mitigate risks during the system switchover.

Harmonise legacy equipment calibration schedules with parent QMS master plans. Validate manual assembly steps Background 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 Understanding of metrology, calibration tolerances, and NIST-traceable standards. PLEASE NOTE THIS IS A CONTRACT ROLE