Our client is making a significant capital investment for a new biologics facility in the USA and requires a Process Engineer to work on the multi-billion-dollar project.
The Process Engineer will be 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 drug product manufacturing to include fill finish and formulation.
Expertise will be provided around the following processes/systems; Formulation, Filling lines, ancillary systems (autoclaves/washers etc.) and packaging.
This role will extend through preliminary & detailed design, construction, commissioning and verification/qualification, PV and start-up.
The Process Engineer 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 (10 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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