22 Mar, 2024

Process Support Engineer / Process Specialist

  • Thermo Fisher Scientific
  • Monza, Province of Monza and Brianza, Italy
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Job Description

 

Position Summary:

Due to site growth and an exciting new project we are looking to recruit an additional Process Specialist at our Swindon site in the UK. You will be focused on supporting our production through commercial product phases, working closely with the operations teams and our Tech Transfer department.

To be successful in this role you will ideally come from a technical or operation background within the Pharma industry and be looking for your next move.

 

Responsibilities

 

Supporting Production in the following:

  • Creation of equipment and process definition.
  • Process documentation generation and approval.
  • Transfer and demonstration of existing process knowledge into the SWC systems.
  • Delivery of effective and safe production manufacturing operations within the agreed organisation framework.
  • Ensuring the process for products to be manufactured is set up and maintained in accordance with GMP, Standard Operating Procedures and other regulatory agency requirements.
  • Involvement in the equipment validation phases on through into routine commercial manufacturing.
  • Actively working with and supporting other members of the project team in delivering the project goals.
  • Being integral in championing and establishing robust lean processes.
  • Liaising with clients and suppliers as appropriate, and becoming a key customer of the client’s person in plant.
  • Supporting the implementation of staff training and development programmes to assure proficiency (suitably qualified and expert personnel) and support the achievement of objectives!.
  • Working as an effective team member, collaborating closely with other SMEs as appropriate to draw in expertise.
  • Solving manufacturing, filling, inspection packaging processes to improve fields.
  • Tracking improvements, presenting solutions to key collaborators.
  • Finish the activities to optimally to acquire and maintain a Bronze license Badge – Production areas (Grade C/D) access.  Maintain the Bronze license through successful requalification every 2 years
  • Maintaining required housekeeping standards.

 

EH&S:

  • Understand emergency procedures and align with safe systems of work.
  • Ensure compliance with environment, health and safety rules, signage and instructions at all times.
  • Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.

 

Qualifications/Experience:

  • Science or Engineering based degree. Ideally Pharmaceutical or Chemical Engineering.
  • Understanding of the end to end manufacturing of aseptic processes (liquids, powders and lyophilisation) is needed.
  • Experience of new facility/process start-up desirable.  
  • Skills for or solid understanding of mechanical and software operation desirable.
  • Proactive approach to work with a willingness to do what needs to be done to deliver against achievements.
  • Pragmatic / common sense approach to problem solving.
  • Proven track record to make sound risk based decisions.
  • Experience in lean operations from documentation and manufacturing processes desirable.
  • Experience of technical writing, production documents such as DR’s, Protocols, SOP’s and BMRs
  • Experience of supporting OE/Lean initiatives.

 

The role may require the holder to travel and work outside of the UK for approximately two week blocks to support equipment validation and process establishment.

 

Please apply in English.

 

About us

When you’re part of Thermo Fisher Scientific, you’ll do exciting work, and be part of a team that values performance, quality and innovation. Within a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

 

At Thermo Fisher Scientific, each one of our 130,000 outstanding minds has a unique story to tell. Join us in our one team mission—enabling our customers to make the world healthier, cleaner and safer!.


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