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.
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.
- 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.
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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