International Pharmaceutical Manufacturer seeks a Technical Specialist - Production Engineering.
About the role:
The main purpose of this role is to provide in-depth technical support to the site. This technical support will cover major investigations, fault-finding, continuous improvement projects, training and planning. The main aim being to provide direction and expertise to the engineering function - in order to develop the knowledge and capability of the operations teams.
Duties may include:
- Support the Planning and Scheduling of investigation work within Engineering
- Major Incident Investigation
- Create and Review Technical Investigation Reports
- Support the identification, recording and trending of Functional Failure and Failure Mode data
- Take ownership of DRs including the creation, investigation and close-out
- Carry out reviews of PM effectiveness
- Provide Technical Support to validation and qualification activities on site
- Act as Subject Matter Experts during regulatory Inspections
- Creating, Reviewing, Updating and of SOPs and BEMPs
- Develop and maintain the Engineering Training matrix, including training records and the version control spreadsheet
- Verifying effectiveness of technicians' training, including checking the knowledge and understanding of SOPs, BEMPs and how systems operate
- Ensuring Work Orders have valuable detail for Asset History
- Carry out plant visits with the Planner to scope out each job and to 'do the job on paper'.
- Provide advice on primary and secondary spare parts, and the most reliable suppliers
- Assisting in all aspects of Projects, including URS Development, Design Work and Approvals
- Act as Subject Matter Experts and Engineering Points of Contact for Capital and Improvement Project work
- Identification of Critical Process Parameters
- Support the implementation of Predictive Maintenance techniques.
- Facilitate the creation of a representative Asset Hierarchy.
- Assist and provide guidance in more complex maintenance tasks (e.g - detailed overhauls)
- Create SOPs and Skills Point Lessons following major investigations.
Skills and experience:
- Ability to Lead Fault-Finding and Root Cause Analysis activities.
- Ability to create and review Technical Reports
- Excellent communicator with the ability to analyse and impart knowledge
- Ability to Create, Review, and Update SOPs
- Ability to develop and deliver technical training to technical and non-technical staff
- Expert knowledge of: Aseptic Filling Lines, Centrifugation, Lyophilisers, Autoclaves, Sterilisation and Depyrogenation Systems, Clean Room Technology, Ultra-Filtration, and Packaging Lines.
- Experience in acting as Subject Matter Experts in Regulatory Inspections.
- Knowledge of Quality Management Systems within a Pharmaceutical GMP Environment
- Knowledge of Engineering Change Control processes, and how they apply during major or minor projects.
- Knowledge of Predictive Maintenance techniques and how to apply them in the field
- Minimum Level 3 qualification in a manufacturing related mechanical/electrical discipline, e.g. advance apprenticeship, NVQ 3, Mechanical/Electrical NC/ND C&G Mechanical/Electrical and Electronic technical certificate.