Process Validation Lead – Medical Device Quality

Medibeam; Cambridge; On-site; GBP 60,000 - 90,000; Full time

Job summary

Medibeam is seeking a Quality Engineer who truly understands process validation and can own the lifecycle from concept and design through IQ, OQ and PQ to final release. The role blends focused validation work with broader quality engineering, using data to spot issues before NCRs or CAPAs.

Initially, expect hands-on validation on site, evolving toward oversight as new equipment and processes are introduced.

Qualifications

• Must genuinely own the process validation lifecycle from concept to release.
• Experience in medical device or pharmaceutical manufacturing preferred.
• Ability to implement risk-based validation rather than tick-box approaches.

Responsibilities

• Own the full process validation lifecycle, including IQ, OQ, PQ.
• Perform risk and impact assessments and drive improvements to validation templates and documentation.
• Use SPC and process capability metrics to monitor processes.
• Identify and address issues to prevent NCRs or CAPAs and improve on-site validation practices.

Skills

Process validation

Quality engineering

Risk assessment

Data analysis

IQ/OQ/PQ

SPC

MSA

Job description

Medibeam is seeking a Quality Engineer who truly understands process validation and can own the lifecycle from concept and design through IQ, OQ and PQ to final release. The role blends focused validation work with broader quality engineering, using data to spot issues before NCRs or CAPAs.

Initially, expect hands-on validation on site, evolving toward oversight as new equipment and processes are introduced.