Our industry leading client is seeking a highly experienced Engineering Improvements Project Manager to develop, manage, and maintain a continuous programme for the replacement and improvement of production equipment and facilities in line with strategic plans, ensuring improved efficiency, reduced unplanned maintenance, and full compliance with cGMP, safety, and regulatory requirements.
The Role:
* Create, review, and maintain GMP documentation including URS, SOPs, Work Instructions (WIs), and Risk Assessments (RAs) in line with regulatory and internal quality standards.
* Support and lead validation activities including FAT support and execution of DQ/IQ/OQ/PQ documentation, protocols, and reports in collaboration with Validation teams.
* Support quality investigations including QIRs, deviations, and complaints, performing root cause analysis and ensuring effective CAPA implementation and closure.
* Drive Lean Manufacturing and Operational Excellence initiatives, identifying and implementing process optimisation and standardisation opportunities.
* Raise and manage Change Controls (CC) to ensure QA approval and compliance for equipment, facility, and process changes.
* All documentation relating to Nelson’s products are kept within Quality Management System (QMS) and adhere to Data Integrity (see POL-002).
* Lead and coordinate site operational and CAPEX projects to improve manufacturing performance, efficiency, compliance, and facility capability.
* Manage cross functional project delivery across Manufacturing, Engineering and Quality, teams, ensuring timelines, scope, and budgets are met.
* Develop short- and long-term capital investment plans and prepare CAPEX proposals, quotations, and business cases for approval.
Qualifications & Skills:
* Degree or equivalent qualification in Engineering.
* Proven experience delivering engineering and CAPEX projects within a GMP-regulated manufacturing environment
* Practical experience with equipment and facility improvements, including GMP validation activities (URS, IQ, OQ, PQ).
* Good working knowledge of Change Control, Risk Assessments, and engineering documentation within a QMS.
Pay & Benefits:
* £(phone number removed) per annum
* Generous pension
* 25 days holiday plus Bank Holidays
* Life assurance x 4 basic salary
* Income Protection 75% salary for up to 5 years
If you meet the above criteria and are ready to work for a company that truly values their team, apply now
Salary description
£63000.00 - £63000.00 per year