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The Senior Project Engineer is a key technical role within the INCOG BioPharma Engineering team, supporting the Drug Product facility focused on formulation, fill, and finish of drug products in vials, syringes, cartridges, and devices. The Senior Project Engineer is responsible for leading the introduction of new fixed assets into the company, which may involve relocating, optimizing existing assets, or purchasing new ones. This role spans from initial conceptual design studies through project closeout, leading a cross-functional team involved in the project.
The Senior Project Engineer will demonstrate strong technical, managerial, and leadership skills in Project Engineering/Management, applying this experience to define user requirements, designs, manage construction, and oversee the commissioning, qualification, validation, and implementation of new assets.
Essential Job Functions:
Drive completion of assigned projects by leading multidisciplinary teams to develop scope, agree on design, and achieve project goals efficiently. Accountable for financial performance of projects, including preparing capital investment proposals, financial justification/benefit analysis, schedule and cost estimate development, and maintaining control over scope, schedule, and budget. Ensure compliance with INCOG requirements for design qualification, safety, change management, commissioning, qualification, and construction control. Lead and interface with INCOG and third-party partners such as architecture/engineering firms, vendors, and clients. Support and execute changes related to new or modified equipment, including defining user requirements, final design, CQV, and issue resolution. Complete equipment investigations and implement corrective and preventative actions. Assist in developing, reviewing, and approving preventive maintenance procedures. Promote clear and open communication among team members and stakeholders. Ensure site and client requirements align with business needs. Special Job Requirements:
Bachelor's degree in Mechanical, Chemical, or Electrical Engineering with at least 5 years of technical experience. Experience with pharmaceutical process equipment such as parts washers, sterilizers, and aseptic fill equipment. Experience with CAPEX budgeting and financial justification processes. Background in project engineering or project management, including scope development, estimation, scheduling, and implementation. Experience with equipment commissioning and qualification. Additional Preferences:
Plant design and construction experience. Utility systems knowledge. Understanding of regulatory requirements for pharmaceutical production and GMP environments. About INCOG BioPharma Services:
We have built a world-class CDMO for parenteral injectable drugs, prioritizing long-term value, technical excellence, and a collaborative, team-centered culture. We seek individuals who enjoy creating systems from scratch and improving business processes to benefit our customers with quality outcomes and faster market access. Most positions are based in Fishers, IN. We are a smoke-free campus and an Equal Opportunity Employer committed to diversity and inclusion. #J-18808-Ljbffr
Drive completion of assigned projects by leading multidisciplinary teams to develop scope, agree on design, and achieve project goals efficiently. Accountable for financial performance of projects, including preparing capital investment proposals, financial justification/benefit analysis, schedule and cost estimate development, and maintaining control over scope, schedule, and budget. Ensure compliance with INCOG requirements for design qualification, safety, change management, commissioning, qualification, and construction control. Lead and interface with INCOG and third-party partners such as architecture/engineering firms, vendors, and clients. Support and execute changes related to new or modified equipment, including defining user requirements, final design, CQV, and issue resolution. Complete equipment investigations and implement corrective and preventative actions. Assist in developing, reviewing, and approving preventive maintenance procedures. Promote clear and open communication among team members and stakeholders. Ensure site and client requirements align with business needs. Special Job Requirements:
Bachelor's degree in Mechanical, Chemical, or Electrical Engineering with at least 5 years of technical experience. Experience with pharmaceutical process equipment such as parts washers, sterilizers, and aseptic fill equipment. Experience with CAPEX budgeting and financial justification processes. Background in project engineering or project management, including scope development, estimation, scheduling, and implementation. Experience with equipment commissioning and qualification. Additional Preferences:
Plant design and construction experience. Utility systems knowledge. Understanding of regulatory requirements for pharmaceutical production and GMP environments. About INCOG BioPharma Services:
We have built a world-class CDMO for parenteral injectable drugs, prioritizing long-term value, technical excellence, and a collaborative, team-centered culture. We seek individuals who enjoy creating systems from scratch and improving business processes to benefit our customers with quality outcomes and faster market access. Most positions are based in Fishers, IN. We are a smoke-free campus and an Equal Opportunity Employer committed to diversity and inclusion. #J-18808-Ljbffr