Process Engineering Lead

Process Engineering Lead required until the end of 2021 initially on a contract basis to support a major greenfield biotechnology investment in the United States of America.

 Our client is investing in a pioneering manufacturing facility to house an array of bio pharmaceutical manufacturing processes.

 Currently at design, stage, the Process Design Lead will be responsible or delivering FEED activities in line with the appointed Engineering House  as Client Representative, responsible for drug Product, laboratories, secondary packaging , warehousing and distribution and supporting utilities.
This role will extend through preliminary & detailed design, construction, commissioning and verification/qualification, PV and start-up.


 The Process Lead will be directly responsible for input to support the design effort and subsequent phases for each of the following elements, throughout the project delivery life cycle of  varied elements of a new manufacturing facility. 

This key role will directly provide design subject matter expertise in Secondary drug product manufacturing to include fill finish and packaging as well as supporting other ancillary buildings.


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 deliverable.
• 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.

 

Qualifications:

• BS in Engineering Discipline (or equivalent)
• Experience of A/E Design Firm project execution
• Minimum (15 years) bio pharmaceutical engineering project experience.
• Previous experience in design of project >$100 MM required
• Knowledge manufacturing processes ideally within the Bio pharmaceutical 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.

Please apply with your CV no to be considered for this long term project with a market leading organisation. 

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

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