Quality Validation Engineer

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

I am looking to speak with Quality Engineers who genuinely understand process validation.

Not just reviewing protocols someone else has written, but actually owning it.

From concept and design, through IQ/OQ/PQ, to final release.

I’m working with a growing Medical Device manufacturer looking for someone to take real ownership of their process validation lifecycle and there’s plenty to get stuck into.

The validation process needs a few tweaks to ensure that the risk based approach flows through properly into what actually happens on the ground, and they want someone who can come in, work out what needs improving and rebuild it properly.

Initially, around 70% of your role will be focused on validation.

You’ll be looking at:

• The full process validation lifecycle
• IQ, OQ and PQ
• Risk and impact assessments
• SPC and process capability
• Measurement System Analysis
• Improving templates and documentation
• Making validation genuinely risk based, rather than a tick box exercise

The other side of the role is broader Quality Engineering.

Using data to understand how processes are actually performing and spotting problems before they become NCRs or CAPAs.

Over time, the role moves more towards oversight.

You’ll be the person setting the standard for validation and guiding teams as new equipment and processes are introduced.

They’re not looking for someone who has supported validation from the sidelines.

You need to have owned equipment or process validation yourself, ideally within Medical Device or pharmaceutical manufacturing, and be confident taking something from concept all the way through to release.

If you’ve done that and want a role where you can actually improve how validation is done, rather than inherit a perfect system and maintain it, this could be a really good one.

Please note, this role is quality within a manufacturing environment focused on improvements to processes, so naturally it is ONSITE.