We're seeking a Engineering Validation Specialist to join our State-of-the-art biomanufacturing facility
Your Mission
Join a pioneering biopharmaceutical team operating in a world-class facility dedicated to delivering breakthrough therapies. As an Engineering Validation Specialist, you’ll ensure that every system, process, and piece of equipment supporting our GxP operations meets the highest standards of quality, safety, and compliance.
You’ll be a key member of a forward-thinking engineering group, shaping validation strategies that support innovation, efficiency, and regulatory excellence.
What You’ll Do
* Provide expert validation support across GxP processes, equipment, facilities, and computerized systems.
* Maintain up-to-date knowledge of EU, UK, and FDA regulations, acting as a subject matter expert in validation and compliance.
* Review and approve qualification protocols, discrepancies, and reports—ensuring timely and compliant delivery.
* Collaborate across departments—Quality, Facilities, Operations, IT, Laboratories, and Process Development—to align validation activities with business and site objectives.
* Represent the company as a validation SME during audits and regulatory inspections, supporting any required responses or remediation actions.
* Drive continuous improvement, ensuring all systems remain inspection-ready and compliant throughout their lifecycle.
* Support QMS activities, including deviation investigations, change controls, and CAPA management.
* Champion Good Engineering Practice (GEP), Good Documentation Practice (GDocP), and Data Integrity principles in all validation activities.
What Success Looks Like
* Validation procedures are consistently fit for purpose, compliant, and aligned with global regulatory expectations.
* GxP systems, facilities, and equipment are qualified, maintained, and ready for inspection at any time.
* Validation documentation and actions are completed right first time and on schedule.
* Strong cross-functional collaboration ensures validation supports operational excellence and innovation.
What You’ll Bring
* A degree in Engineering, Life Sciences, or a related field.
* At least 5 years of experience in an engineering validation role, with a strong background in Computer System Validation (CSV).
* Proven understanding of GxP, cGMP, and validation/qualification principles across manufacturing and laboratory environments.
* Experience communicating with regulatory authorities during inspections is an advantage.
* Exceptional written and verbal communication skills, with the ability to convey complex information clearly.
* A logical, solution-oriented mindset and the flexibility to thrive in a fast-paced, innovative environment.
Why Join Us?
You’ll be part of a dynamic and growing organization where cutting-edge science meets advanced engineering. Our facilities are equipped with the latest technologies, providing an inspiring environment for professionals who take pride in precision, compliance, and innovation.
This is your opportunity to make a real impact—supporting the development of transformative therapies while ensuring the integrity of every system that makes them possible.
Interested? Apply now to discuss further!