Capital Project LeaderThis 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 budgetCreate 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 ProtocolsUtilize latest CPMP principles to support project successCoordinate with internal teams, external stakeholders, and vendors to ensure project objectives are metPrepare technical documentation such as drawings, specifications, and reportsIdentify and support permitting requirements, as neededMonitor project progress, identify and escalate potential risks, and recommend solutions to mitigate issuesSupport procurement activities, including sourcing materials and equipment, to include negotiating with suppliers/vendorsIdentify, procure, and manage vendors and subcontractorsPerform and support feasibility studies for equipment replacements, utility systems, and facility modificationsEnsure compliance with any of the following as relevant: 21 CFR, GxP, OSHA, APHIS, USP, EHS, Client company policiesMaintain clear communication with vendors, subcontractors and contractors, and clients and stakeholdersPrepare regular status updates and progress reports for project stakeholdersAssist in commissioning and qualification phases to verify system performance and complianceDevelop and improve User Requirement Specifications (URS), working directly with operations and end users to translate process needs into well-defined project requirementsDevelop 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 definitionRequirements:Applicants must have prior direct experience in a biotech, pharmaceutical, or animal health manufacturing environment to be consideredBachelor'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 labelingMust 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 requirementsStrong working knowledge of biologics and pharmaceutical manufacturing processes and end-user needs; ability to translate operational requirements into well-defined capital project scopeProven experience and expert knowledge in the use of project management tools and methodologiesMust have direct experience writing business cases and project proposals to secure funding, including managing the project budget across the lifecycleMust have direct experience sourcing and managing vendors and subcontractorsMust have direct experience sourcing and procuring equipment and componentsProven ability to influence decision making with executive level stakeholdersProven exceptional social and diplomacy skillsProven ability to lead and manage a team across a multi-departmental project with direct and indirect management of functional resourcesExcellent communication and organization skills, with an analytical and problem-solving mindsetDocumented success leading capital projects in excess of $5MMProven ability to operate under high-pressure in a timeline constrained environmentMust be fully on-site at the client's manufacturing facility in the Midwest; remote or hybrid arrangements are not available for this roleCollaborative, 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 workingComfortable working as both an independent contributor and a collaborative team member alongside existing project engineers; able to elevate the capabilities of those around youOpen to coaching and feedback; brings outside perspective with humility, appreciating that site-level knowledge is valuable and change must be introduced thoughtfullyPre-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.