About the position
The Senior Project Engineer is a key technical role within the INCOG BioPharma Engineering team supporting the Drug Product facility focused on the formulation, fill and finish of drug product in vials, syringes, cartridges and devices. The Senior Project Engineer is responsible for leading the introduction of new fixed assets into the company. This could involve relocating and optimizing the existing fixed asset base and/or the purchase of new fixed assets. It may extend from initial conceptual design studies through project closeout and will include leading a cross functional team participating in the project. The Senior Project Engineer will demonstrate strong technical, managerial and leadership skills in Project Engineering/Management and will apply this experience to define user requirements, designs, manage construction, and commission, qualify, validate and implement new assets.
Responsibilities
- Drive completion of assigned projects by leading multi-disciplinary teams that develop scope, agree on design, and efficiently achieve project goals.
- Financial performance accountability for assigned projects including preparation of capital investment, financial justification/benefit, schedule and cost estimate development, and maintenance and control of project scope, schedule, and budget.
- Ensure INCOG requirements for design qualification, safety, change management, commissioning, qualification, and construction control are satisfied.
- Lead and provide an interface with INCOG and third-party partners (Architecture/Engineering firms, vendors, clients).
- Support and execute changes associated with new or modified equipment, including user requirements definition, final design, CQV and issue resolution.
- Responsible for completing equipment investigations and implementation of associated corrective and preventative actions.
- Assist in developing, reviewing, approving new and/or current preventive maintenance procedures.
- Support and encourage clear and open communication between the team members and related stakeholders.
- Ensure the site and/or client requirements are maintained in accordance with the business needs.
Requirements
- BS in Engineering Field (Mechanical, Chemical, Electrical Engineering) and a minimum of 5 years of technical experience.
- Experience with Pharmaceutical Process Equipment (Parts Washers, Sterilizers, Aseptic Fill Equipment).
- CAPEX budgeting and financial justification processes.
- Previously in a project engineering or project management role including scope development, project estimation, schedule development and project implementation.
- Equipment commissioning and qualification.
Nice-to-haves
- Plant design and construction.
- Utility systems.
- Regulatory requirements for pharmaceutical production and equipment in a GMP environment.
