Process/Building Lead

Process/Building Lead - Global Biopharmaceutical Client - USA

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


The Role:

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 Secondary drug product manufacturing to include fill finish and packaging.

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

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

The Process Lead 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 (15 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.



The candidate must have the rights to work in the location stated in the job advert.

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