Project Engineer, Quality Engineering

Are you interested in progressing your career in life sciences? Are you ready to challenge yourself and join a global leader in medical device technology? If you have a background in the qualification and validation of manufacturing equipment, this could be the perfect opportunity for you. Don't hesitate, apply today!

Our client are seeking an experienced Project Engineer to support the consolidation of legacy manufacturing equipment to release manufacturing-floor space for expansion of a new sensor manufacturing capability. You will play a key role supporting equipment being decommissioned and relocated, reinstalled, and revalidated in its new location. Moves will be phased to maintain ongoing production. Day-to-day activities are roughly 50% documentation and 50% execution.

• Get up to speed quickly with client QMS, procedures, training and familiarisation with the equipment and existing validation packages
• Review historical equipment validation packages and previous client decommissioning/move documentation
• Understand equipment operation, process requirements, CQAs/CPPs and inspection/testing
• Prepare decommissioning, equipment-move and revalidation documentation
• Coordinate equipment moves with Maintenance/Facilities/EHS and other stakeholders
• Ensure utilities and other prerequisites are ready for relocated equipment
• Execute validation testing on the shop floor with operator/technician support
• Investigate failed tests/issues and coordinate resolution
• Work closely with Quality to resolve comments and drive documentation through approval.

• Experience qualifying/validating manufacturing equipment in a highly regulated environment - medtech, pharma, biopharma all suitable
• Experience with equipment commissioning/qualification and FAT/SAT, IQ/OQ/PQ or equivalent
• Able to understand existing URS, functional/design specifications and validation packages
• Strong validation/documentation capability
• Comfortable executing validation protocols directly on manufacturing equipment/shop floor
• Able to own documentation through review/approval rather than simply write documents and pass them on
• Strong stakeholder/project coordination skills - Quality, Maintenance, Facilities, technicians, operators etc.
• Able to work independently and drive activities forward.

• Competitive and attractive employee compensation package
• Pension contributions
• Health insurance
• Paid holidays

Location:

Oxfordshire, England | on-site