Overview
Global Head of Engineering Recruitment, full product life cycle within Medical Devices, Scientific and Life Sciences.
Responsibilities
* The Process Engineer will provide operational and project engineering support to maintain reliable and compliant operation of manufacturing and packaging equipment within the Hatfield facility.
* Ensure operations are carried out in accordance with the Quality System, GMP Guidelines and Industry Standards, Corporate Standards, Quality System, GMP and GDP Guidelines and Industry Standards.
* Maintain a safe working environment and ensure all near miss incidents and accidents are reported in accordance with procedures.
* Assure the quality of products manufactured and released by adhering to all procedures.
* Identify and progress opportunities to improve operations and reduce costs through continuous improvement and demand innovation initiatives.
* Engage with stakeholders and customers to understand and meet expectations through effective communication.
* Coordinate with Production Engineering, Utilities Engineering, Facilities Management Engineering, Production Operations, Project Key Sponsors and Stakeholders, Quality Operations and Quality Systems, EHS, Technical, EIT / Manufacturing business systems, Compliance, Business Effectiveness and Legal departments.
General
* Provide engineering technical expertise to support site operations in accordance with GMP and Good Engineering Practice (GEP).
* Optimise manufacturing and packaging plant and equipment to improve reliability and efficiency in terms of cost and availability.
* Deliver improvements to equipment reliability and availability, maintaining metrics and KPIs to demonstrate performance.
* Resolve complex problems that do not have routine solutions and provide support to craft and technician personnel when technical issues are escalated.
Compliance
* Coordinate and participate in risk assessments and method statements for specified work.
* Undertake Change Management, Deviation Investigation, CAPA activities, root cause analysis (RCA) and continuous improvement projects.
* Participate in internal and external audits and generate Standard Operating Procedures for Engineering and related activities.
* Participate in Critical Device/Instrument assessments and develop associated Critical Device lists.
Maintenance
* Define maintenance regimes for process equipment, considering manufacturer recommendations, production drivers and GMP/GEP requirements.
* Manage external contractors for specialist maintenance activities, including feedback and performance monitoring.
* Define equipment spares requirements, identifying specifications, sources of supply and stock levels.
* Compile critical equipment information and hierarchies for input into the site's maintenance management system.
Projects
* Advise on equipment selection, participate in detailed design development and work with technical services to implement robust solutions for reliability.
* Lead or coordinate project planning, resourcing, reporting, and commissioning activities for engineering projects.
* Lead commissioning activities to certify equipment operates as designed and to ensure installation and qualification tasks are executed smoothly.
* Support Technical Services in qualification and validation of equipment.
* Qualifications and experience: HNC/HND/Degree in a relevant engineering discipline (e.g., chemical, electrical, mechanical); EngTech / IEng or working towards professional status; Project Management training – CAPM / PMQ (or equivalent); Professional membership - IMechE, IET, PMI, APM, ISPE (or similar).
* Practical experience of GMP manufacturing, packaging processes and/or equipment within MHRA / FDA regulated facilities; awareness of commissioning, qualification, and validation project activities.
* Tech-savvy with a growth mindset and strong self-development focus.
* Excellent oral and written communication, problem solving and root cause analysis; attention to detail and clear documentation; ability to work independently and in a multidisciplinary team.
* Ability to prioritise workload, make decisive decisions, and adapt to changing operational needs.
* Technology enthusiast.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Staffing and Recruiting and Pharmaceutical Manufacturing
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