Marketplace Technical

Technical Specialist - Production Engineering

Expiring today

Hertfordshire, England, Borehamwood
12 Jan 2021
19 Jan 2021
Andrew Williams
Full Time
Contract Type
Experience Level

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

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