Marketplace Technical

Technical Specialist - Production Engineering

Expiring today

Location
Hertfordshire, England, Borehamwood
Salary
Negotiable
Posted
12 Jan 2021
Closes
19 Jan 2021
Ref
MATECBB326AA11
Contact
Andrew Williams
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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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