Senior Process Engineer
Senior Process Engineer (Media & Buffer) - 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.
The Role:
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.
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.
To view Quanta's privacy policy, please visit our website
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.
The Role:
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.
- Must have experience with Media & Buffer prep process 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.
- 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.
To view Quanta's privacy policy, please visit our website
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Waste Systems WPO - Global Biopharmaceutical Client – USA Our client is making a significant capital investment for a new biologics facility in the USA and requires a Waste Systems WPO to work
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