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.