Senior Process Engineer - BPL Recruitment


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Jobs: Engineering

Senior Process Engineer

Department
Process Engineering
Job Type
Permanent
Posted
27/06/2017
Closing
30/10/2017
Salary Grade
Competitive
Job Band
C

Details

  

  • Leading and 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 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/reviewing vendor feasibility studies, concept/detailed designs, URSs, design specifications; design/GMP reviews, commissioning plans and validation documentation
  • Supporting installation, commissioning, FATs, SATs and validation of new processes and equipment, monitoring effectiveness
  • Providing accurate budget estimates for capital equipment and projects;
  • Investigating complex 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 standardsProvide process safety support/expertise (HAZOP, ATEX etc). ensuring that all processes and changes that are implemented result in a safe process; 

    Qualifications and Experience

    • Degree Level Education preferably in Chemical Engineering or other related engineering discipline
    • 7+ years' experience working in the Pharmaceutical industry, preferably in a sterile manufacturing environment with experience of protein and biochemical processing unit operations.
    • Proven scale-up and technology transfer experience. Knowledge of chromatography, filtration (ultra/dia/viral), lyophilization and aseptic filling processes is desirable
    • Strong understanding of Process Engineering fundamentals with practical experience of designing pharmaceutical processes and utility systems to cGMP and regulatory requirements.
    • Knowledge in the application of safety standards (e.g. PED, pressure relief assessment)
    • Experience in developing process engineering site standards, process reliability and capability programmes desired
    • Experience with documentation and practices in a regulated environment (e.g. GxP, FDA, MHRA)

    Skills

    • Strong leadership skills
    • Excellent communication skills in both verbal and written forms and ability to describe complex process engineering matters to technical and non-technical people
    • Proven skills in working/leading interdisciplinary teams to deliver projects, troubleshoot technical issues and implement effective permanent solutions
    • Demonstrated attention to detail and organisational skills needed to successfully execute multiple activities and prioritize work load.
    • Be able to build effective internal and external relationships and influence individuals across a variety of functions without a direct reporting relationship.

 


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