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Process Engineer

  1. East Coast
  1. Contract
Competitive
26513
  1. CAPEX Projects
Date Posted08 Apr 2021
Process Engineer DP Filling - Global Biopharmaceutical Client - USA

Our client is making a significant capital investment for a new biologics facility in the USA and requires a Process Engineer to work on the multi-billion-dollar project.

The Role:
The Process Engineer will be directly responsible for input to support the design effort and subsequent phases for each of the following elements, throughout the project delivery lifecycle of a new secondary drug product high-capacity manufacturing facility:

This key role will directly provide design subject matter expertise in drug product manufacturing to include fill finish and formulation.

Expertise will be provided around the following processes/systems; Formulation, Filling lines, ancillary systems (autoclaves/washers etc.) and packaging.

This role will extend through preliminary & detailed design, construction, commissioning and verification/qualification, PV and start-up.

The Process Engineer will be responsible for providing engineering and process insight on the project.
  • Direct process expertise to be provided within the above-mentioned systems.
  • Provide client technical engineering input to scope definition, specification, and procurement for all equipment.
  • Review and approval of A/E firm engineering design deliverables.
  • Review and approval of equipment package bid analyses.
  • Provide engineering input into overall facility layout and design.
  • Support input to the development of detailed capital project execution schedule.
  • Ensure design documents are maintained through project life-cycle for turnover.
  • Identify project risks and opportunities and propose mitigation plans.
 
Requirements:
  • BS in Engineering Discipline (or equivalent).
  • Experience of A/E Design Firm project execution.
  • Minimum (10 years) biopharmaceutical engineering project experience.
  • Previous experience in design of project >$100 MM required.
  • Knowledge of fill finish / drug product manufacturing processes ideally within the biopharmaceutical or vaccines industry.
  • Knowledge and experience of project execution for fully automated facility design.
  • Experience of Equipment vendor package management and design coordination.
  • Knowledge and experience of Bio-pharmaceutical commissioning & qualification.
  • Good understanding of risk management methodologies, with a proven ability to apply in Bio-pharmaceutical operations.
 If this opportunity interests you, please apply today.



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