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
  

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 methodologies


• Must have direct experience writing business cases and project proposals to secure funding, including managing the project budget across the lifecycle


• Must have direct experience sourcing and managing vendors and subcontractors


• Must have direct experience sourcing and procuring equipment and components


• Proven ability to influence decision making with executive level stakeholders


• Proven exceptional social and diplomacy skills


• Proven ability to lead and manage a team across a multi-departmental project with direct and indirect management of functional resources


• Excellent communication and organization skills, with an analytical and problem-solving mindset


• Documented success leading capital projects in excess of $5MM


• Proven ability to operate under high-pressure in a timeline constrained environment


• Must be fully on-site at the client’s manufacturing facility in the Midwest; remote or hybrid arrangements are not available for this role


• Collaborative, patient, and relationship-driven approach to leading change at a site with deep institutional knowledge; must be able to build trust with operators and engineers before pushing new ways of working


• Comfortable working as both an independent contributor and a collaborative team member alongside existing project engineers; able to elevate the capabilities of those around you


• Open to coaching and feedback; brings outside perspective with humility, appreciating that site-level knowledge is valuable and change must be introduced thoughtfully

Pre-Employment Requirements: 

• Pass and maintain pre-employment/contract background check and safety certification, including but not limited to outstanding professional references.


• Subject to motor vehicle report review.


• Maintain valid driver’s license and endorsements as required per position.


• Pass pre-employment/contract physical, medical evaluation, and drug screen due to the safety sensitive nature of this position.


• Successfully complete and maintain any required safety certification and testing on an annual basis.

Work Environment Expectations

• This role is expected to be on-site full time at the client facility.