Project Engineer​/W2

Capital Project Leader

This is an opportunity to lead equipment, facility, and utility capital projects at a large biomanufacturing site in the Midwest. Be part of an exciting start-up that supports the world's leading pharmaceutical, biotech, food, and animal health companies. Get the best of both worlds. Gain experience at a company that leads projects for global pharmaceutical companies while enjoying the flexibility, energy, and personal attention that can only be found working in a small, close-knit company.

Applicants must have prior experience in biotech, pharmaceutical, or animal health industries to be considered.

Essential Duties:

• Support capital projects across the project lifecycle (Concept to Closeout)
• Develop comprehensive project documentation, including scope, schedule, WBS, and budget
• Create and develop documentation across the project lifecycle as needed, to include Capital Project Appropriation requests (CPAs), RFPs, Capital Plan, Capital and Expense budget requests, URS, FS/DS, Project plans, Master Project Schedules, WBS, Business Case, SAT/FAT protocols, IOPQ Protocols
• Utilize latest CPMP principles to support project success
• Coordinate with internal teams, external stakeholders, and vendors to ensure project objectives are met
• Prepare technical documentation such as drawings, specifications, and reports
• Identify and support permitting requirements, as needed
• Monitor project progress, identify and escalate potential risks, and recommend solutions to mitigate issues
• Support procurement activities, including sourcing materials and equipment, to include negotiating with suppliers/vendors
• Identify, procure, and manage vendors and subcontractors
• Perform and support feasibility studies for equipment replacements, utility systems, and facility modifications
• Ensure compliance with any of the following as relevant: 21 CFR, GxP, OSHA, APHIS, USP, EHS, Client company policies
• Maintain clear communication with vendors, subcontractors and contractors, and clients and stakeholders
• Prepare regular status updates and progress reports for project stakeholders
• Assist in commissioning and qualification phases to verify system performance and compliance
• Develop and improve User Requirement Specifications (URS), working directly with operations and end users to translate process needs into well-defined project requirements
• Develop deep understanding of site manufacturing processes — including upstream biologics production, formulation, lyophilization, filling, and packaging — and apply that knowledge to drive better front-end project definition

Requirements:

• Applicants must have prior direct experience in a biotech, pharmaceutical, or animal health manufacturing environment to be considered
• Bachelor's degree in an engineering field (Mechanical, Chemical, Biomedical preferred)
• At least 10 years in a project engineering or project management role in Design/Build Capital projects within an FDA regulated production facility, with primary experience in biologics, pharmaceutical, or animal health manufacturing. The following process areas are a plus but not required: upstream biologics production (bioreactors, stainless steel tanks, single-use systems), vaccine or biologics manufacturing (monoclonal antibodies, vaccines, bacterins), lyophilization, aseptic filling, formulation, weigh and dispense, wet or dry granulation, blending, compression, film coating, packaging and labeling
• Must have direct experience leading Capital projects across equipment, utilities, and facilities in a regulated manufacturing environment (e.g., HVAC/AHU systems, WFI/purified water systems, clean steam, compressed gases, electrical distribution, roofing, and building infrastructure)
• Demonstrated experience authoring or developing User Requirement Specifications (URS) and working collaboratively with operations, engineering, and quality stakeholders to define project requirements
• Strong working knowledge of biologics and pharmaceutical manufacturing processes and end-user needs; ability to translate operational requirements into well-defined capital project scope
• Proven experience and expert knowledge in the use of project management tools and…