Technical Specialist - Production Engineering

International Pharmaceutical Manufacturer seeks a Production Engineering Technical Specialist.

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 Deliver Technical Training
• 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'.
• Improve the Planner's plant knowledge
• Provide advice on primary and secondary spare parts, and the most reliable suppliers
• Assist in regular plant walk-downs to identify potential improvement opportunities and areas of concern
• Raising, Managing and providing Technical Support to Change Controls
• 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
• Own and support actions from Downtime Review, and the Red Box and Heat Map Projects
• 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.
• Creating Troubleshooting Guides

Skills and experience:

• 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