Senior Process Engineer
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.
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.
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.
- BS in Engineering Discipline (or equivalent).
- Experience of A/E Design Firm project execution.
- 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
- Knowledge of Delta V.
- 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.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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