Project Engineer - 1099/W2

Do you want to get out of the corporate grind of meetings? Do you excel at leading capital projects that require you to be a great planner, negotiator, and change leader? Are you up to the challenge of leading the transformation of a facility? Do you thrive in environments where change isn’t easy and requires finesse?

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

Pre-Employment Requirements