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?

• 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

• 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 elevate 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

• 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…