Our client is making a significant capital investment for a new biologics facility in the USA and requires a Process/Building Lead DSM 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 Drug Substance high-capacity manufacturing facility:
This key role will directly provide design subject matter expertise in Large Scale Drug substance manufacturing to include Upstream, Downstream, Support equipment and associated utility systems.
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 (15 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.
CQV Lead Drug Substance Upstream & Downstream - 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 - 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
CSV Lead - Global Biopharmaceutical Client - USA Our client is making a significant capital investment for a new biologics facility in the USA and requires a CSV Lead to work on the
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.