Process Engineer

6 days ago

Hatfield, United Kingdom Cpl Life Sciences Full time

Our client a Pharmaceutical Company based in Hertfordshire are currently looking to appoint a Process Engineer due to recent funding and will provide operational and project engineering support in order to maintain reliable and compliant operation of themanufacturing and packaging equipment within their Manufacturing facility.

**Role Responsibilities**:
Provide engineering technical expertise to support the operations of site in accordance with Good Manufacturing Practice (GMP) and Good Engineering Practice (GEP).

Optimisation of manufacturing and packaging equipment to ensure reliability and efficiency in terms of cost and availability.

Deliver improvements to equipment reliability and availability, maintaining metrics and KPI to demonstrate performance.

Resolves complex problems that do not have routine solutions

Provide support to craft and technician grade personnel when technical issues are escalated.

Co-ordinate and participate in the development of risk assessment and method statements associated with specified work.

Undertake Change Management, Deviation Investigation, Corrective Action and Preventative Action (CAPA) activities, root cause analysis (RCA) and continuous improvement projects.

Participate in internal and external audits.

Generate Standard Operating Procedures for Engineering and related activities.

Participate in Critical Device/Instrument assessments and development of associated Critical Device lists.

Define maintenance regimes for process equipment taking account of manufacturers recommendations, production drivers and GMP and GEP requirements.

Management of external contractors for the execution of specialist maintenance activities, including feeding back and monitoring on performance.

Define equipment spares requirements, identifying specifications, sources of supply and stock levels.

Compile critical equipment information and hierarchies for input onto the site's controlling maintenance management system.

Advise on equipment selection, participating in detailed design development and working with technical services to ensure robust solutions are implemented to ensure reliability.

Leads or coordinates project planning, resourcing, reporting, commissioning activities for engineering projects.

Lead commissioning activities to certify equipment will operate in accordance with design intent and to ensure installation and qualification tasks are executed smoothly.

Support technical services in the qualification and validation of equipment.

**Skills and Qualifications**:
HNC/HND/Degree qualified in a relevant engineering discipline (e.g., automation, chemical, electrical, mechanical engineering)

EngTech / IEng or working towards professional status.

Project Management training CAPM / PMQ (or equivalent).

Understanding / training in Lean Six Sigma

Professional membership - IMechE, IET, PMI, APM, ISPE (or similar)

Practical experience of GMP manufacturing, packaging processes &/or equipment within MHRA / FDA regulated facilities.

Demonstrable awareness of commissioning, qualification, and validation project activities.

Comfortable with technology.

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