Senior Process Engineer

Senior Process Engineer (CIP & Support Equipment) - Global Biopharmaceutical Client - USA

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


Responsibilities:

Provide client engineering input to support the design effort and subsequent phases for each of the following elements, throughout the project delivery lifecycle of a new Drug Substance high capacity manufacturing facility:

This key role will directly provide process design subject matter expertise in cell culture, transfection, purification, and support services design for a new manufacturing operation. Specifically, the design and specification of CIP & Support equipment.

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

This individual will interface with automation and verification colleagues to ensure streamlined start-up and handover of the facility to operations team members, as well as seamless integration into site engineering and automation systems.

• Process engineering group.
• Provide client technical engineering input to scope definition, specification and procurement for all process equipment.
• Review and approval of A/E firm process 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
• Provide engineering input into cost estimate preparation for the project.
• Ensure design documents are maintained through project life-cycle for turnover.
• Develop general procedures, metrics and deliverables in support of successful delivery of the project objectives on time and within budget.
• Identify project risks and opportunities and propose mitigation plans.
• Support with the commissioning and verification of the project – oversight from a process perspective of associated protocols.

Requirements:

• BS in Engineering Discipline (or equivalent).
• Experience of A/E Design Firm project execution.
• Must have experience with CIP & Support equipment.
• Minimum (5 years) biopharmaceutical engineering project experience.
• Previous experience in design of project >$100 MM is ideal.
• Knowledge of upstream, downstream processes within either cell culture or vaccines manufacturing facilities.
• Direct operational experience within either cell culture or vaccines manufacturing facilities.
• 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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