Project Engineer - 1099/W2

GMP Pros, Inc.•Lincoln, NE

26d•Onsite

About The Position

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.

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.
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
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.

Nice To Haves

Upstream Biologics Production (bioreactors, stainless steel systems, 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

Responsibilities

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