Process/Building Lead
- East Coast
- Contract
- CAPEX Projects
This vacancy has now expired
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.
The Role:
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.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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