Senior Project Engineer

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. Essential Job Functions:

• 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.

Special Job 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.

Additional Preferences:

• Plant design and construction.
• Utility systems.
• Regulatory requirements for pharmaceutical production and equipment in a GMP environment.

Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.