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Process Engineer

Based in Borehamwood/Elstree, Hertfordshire, we have an exciting opportunity to join the Technology Group as a Senior Process Engineer within an organisation that provides a continuous supply of reliable, high quality plasma-derived products worldwide, supporting both healthcare professionals and patients every day.

 

Main Purpose of the role

  • Support process engineering activities for production of plasma-derived products in a pharmaceutical, GMP environment
  • Provide technical expertise on all aspects of process engineering including feasibility studies, concept and detailed design, constructability, commissioning, and operation etc.
  • Support cross functional projects including process & utility improvements and technology transfer
  • Support and improve process reliability through root cause analysis and troubleshooting of existing processes and equipment
  • Provide process support to resolve quality deviations and safety incidents

 

Key Responsibilties

  • Providing technical expertise on cross-functional projects including process/utility improvement, technology transfer and new product introduction
  • Process design and design of development studies for the scale-up of simple lab-scale processes into commercially viable large-scale operations in conjunction with R&D
  • Assessing new and existing processes for reliability, quality, safety, best practice and adherence to cGMP and regulatory requirements
  • Preparing data sheets, URS, commissioning plans and validation documentation
  • Supporting installation and commissioning of new processes and equipment, monitoring effectiveness
  • Supporting development of accurate budget estimates for capital equipment and projects
  • Investigating simple engineering problems, troubleshooting existing processes and determining root cause and solutions
  • Preparing mass and heat balances, design calculations, hydraulic assessments, process flow diagrams P&IDs and other engineering documentation
  • Assisting with the development and implementation of site engineering standards
  • Providing process safety support (HAZOP, ATEX etc). ensuring that all processes and changes that are implemented result in a safe process
  • Knowledge and understanding critical process parameters and critical quality attributes/authoring and executing protocols/authoring reports. In depth understanding of ICH Q8, FDA published guidance and EudraLex Volume 4 all chapters and relevant annexes.
  • Knowledge of method / equipment / process validation and some experience in implementation
  • Knowledge of Regulatory expectations/Bracketing approaches to validation/understanding the pre-requisites required prior to Process Performance Qualification
  • Bracketing approaches to validation. Knowledge and understanding critical process parameters and critical quality attributes (Good knowledge of ICH Q8 and specific market guidance/regulations)
  • Can specify and design complex equipment e.g., vessels, distillation columns, virus filters and specify control systems with guidance
  • Able commission simple process equipment e.g., pumps, filter without supervision
  • Has in depth knowledge of a single BPL manufacturing process stream and equipment. Able to propose incremental improvements. Can own and deliver multiple tasks and subtasks in support of a major MO objective.
  • Uses relevant OE tools e.g., process mapping, FMEA, RCA to assigned MO activities – Should be a regular JDI contributor. Has awareness of 7 quality tools for data analysis and DMAIC. Can be an accredited white belt and may have attended yellow belt training.
  • Has a basic skill set for collection, analysis and interpretation of process data and information.
  • Participates in audits, both internal and external and deemed competent by line manager / QA to represent functional area with support. Supports department in audit inspection preparation activities and knowledgeable in relevant BPL SOPs and Policies.
  • Significant manufacturing experience at BPL or in previous role. Good knowledge of at least one manufacturing process performed on site and able to provide process support and troubleshoot issues.  Able to operate or write instructions for specific equipment items.
  • Plays as significant role in multiple Mission Objectives or has a history of similar experience. Takes ownership of their own work to ensure the projects are delivered to agreed timelines.
  • Able to author H&S documentation for local team and manage the H&S of matrix team members. Knowledgeable of UK H&S regulations (e.g. The Health and Safety at Work Act) and responsibilities detailed within.  Able to understand industry guidance and translate that for own working area.
  • Able to assess safety / quality risks for own area and mitigate any risks.
  • Able to train Operators / team members on process, equipment modifications etc relaying all pertinent safety and quality information. Able to assess trainees
  • Delivers supporting data / work packages required for Technical Transfer of an internal project
  • Able to create new and update existing documents with minimal support and supervision.

If this role sounds interesting to you please do consider applying today

 

 

We are an organisation where our products change people’s lives, and the purpose of our work is lived and breathed through its people.  Since privatising from the NHS in 2013, BPL has gone through huge change and growth as we aspire to be the leader in our field.  BPL is based in Borehamwood, in a secure campus surrounded by natural beauty, lakes and wildlife.

 

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