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