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

Responsibilities

• 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.
• 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.
• Strong, working knowledge of regulatory guidelines and standards like FDA 21 CFR Part 11 & ISO13485.
• Understanding of metrology, calibration tolerances, and NIST-traceable standards.

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