Engineering Manager

A extremely exciting opportunity for an Engineering Manager to form part of the management team of a new 2 Billion USD large scale manufacturing facility build in the USA.

This individual will be required to support the Drug Product & Site development aspect of this programme totalling between 2 – 300 million USD.

A long-term project, with huge scope. Reporting into the Project Director, This individual will be responsible for the engineering activities within the delivery of the Secondary Drug Product building, Warehousing, CUB and labs.

Responsibilities:

The Engineering Manager will manage a team providing 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 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 as well as supporting the warehouse, lab and central utilities building.

This role will extend through preliminary & detailed design, construction, commissioning and verification/qualification, PV and start-up.

The Engineering Manager will be responsible for leading a team providing engineering and process insight on the project. In addition, this team will interface with automation and verification colleagues to ensure streamlined startup and handover of the facility to operations team members, as well as seamless integration into site engineering and automation systems.

Qualifications:

• 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
• 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 facility design in a 3D Model / BIM environment utilizing integrated project delivery.
• Experience with 3D model and client design reviews.
• 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.

For further information please apply!

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