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