- 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.
