Senior Capital Project Engineer / Project Manager

Intellectt INC
  • Lincoln, NE
  • Instant Apply
6 days ago

Job Description

Job Title: Senior Capital Project Engineer / Project Manager
Location: Lincoln, Nebraska - Fully Onsite
Experience: 10+ years
Industry: Biotechnology, Pharmaceutical, or Animal Health Manufacturing

Position Summary
Seeking an experienced Capital Project Engineer / Project Manager to lead equipment, utilities, and facility projects from concept through commissioning, qualification, and closeout. The role requires strong front-end project planning, requirements development, budget ownership, and vendor management. Prior direct experience in biotech, pharmaceutical, or animal health manufacturing is mandatory.

Key Responsibilities

  • Lead capital projects across scope development, design, procurement, construction, commissioning, qualification, and closeout.
  • Develop business cases, funding requests, project proposals, budgets, schedules, and work breakdown structures (WBS).
  • Work with Operations, Engineering, Quality, and end users to develop User Requirement Specifications (URS) and define project scope.
  • Prepare or coordinate RFPs, technical specifications, design documents, FAT/SAT protocols, and IQ/OQ/PQ documentation.
  • Source and procure equipment; negotiate with and manage vendors, contractors, and subcontractors.
  • Conduct feasibility studies for equipment replacements, utility upgrades, and facility modifications.
  • Monitor project costs, schedules, risks, and progress; communicate updates and escalate issues.
  • Support permitting, EHS requirements, and compliance with applicable 21 CFR, GxP, OSHA, APHIS, USP, and company standards.
  • Build strong working relationships with site teams and support improvements through a collaborative approach.

Required Qualifications

  • Bachelor's degree in Engineering; Mechanical, Chemical, or Biomedical Engineering preferred.
  • 10+ years of capital project engineering or project management experience in FDA-regulated biotech, pharmaceutical, or animal health production facilities.
  • Documented success leading capital projects exceeding $5 million.
  • Direct experience delivering equipment, utilities, and facility infrastructure projects.
  • Proven experience developing URS documents, business cases, funding proposals, and lifecycle budgets.
  • Hands-on experience sourcing equipment and managing vendors and subcontractors.
  • Strong project management, technical documentation, stakeholder communication, and cross-functional leadership skills.
  • Ability to work independently, accept feedback, and build trust with experienced site personnel.
  • Availability to work full-time onsite in Lincoln, Nebraska.

Preferred Process Experience
Biologics or vaccine production, bioreactors, single-use systems, formulation, lyophilization, aseptic filling, weigh and dispense, granulation, blending, compression, coating, packaging, or labeling. Relevant utility experience includes HVAC/AHUs, WFI/purified water, clean steam, compressed gases, electrical distribution, and building infrastructure.

Recruiter Contact:
Pavani Samboju
Email:pavani.samboju@intellectt.com.
Phone:732 993 4972

Benefits:
Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.
Equal Employment Opportunity
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Numbers & Facts

LocationLincoln, NE

Skills

  • Animal Careunmatched
  • Biomedical Engineeringunmatched
  • Biotech and Pharmaceuticalunmatched
  • Budgetingunmatched
  • Business Caseunmatched
  • Capital Projectunmatched
  • Code of Federal Regulationsunmatched
  • Commissioningunmatched
  • Constructionunmatched
  • Cross-Functionalunmatched
  • Design Documentunmatched
  • Documentationunmatched
  • Electricityunmatched
  • Equipment Replacementunmatched
  • FDA (Food and Drug Administration)unmatched
  • Feasibility Analysisunmatched
  • Fundingunmatched
  • GxPunmatched
  • HVACunmatched
  • Leadershipunmatched
  • Manufacturingunmatched
  • Negotiation Skillsunmatched
  • OSHAunmatched
  • Process Validationunmatched
  • Project Engineeringunmatched
  • Project Planningunmatched
  • Project Scheduleunmatched
  • Project Trackingunmatched
  • Project/Program Managementunmatched
  • Proposal Writingunmatched
  • Purchasing/Procurementunmatched
  • Regulatory Complianceunmatched
  • Requirements Managementunmatched
  • Team Playerunmatched
  • Technical Writingunmatched
  • Technical/Engineering Designunmatched
  • User Interface/Experience (UI/UX)unmatched
  • Vendor/Supplier Managementunmatched
  • Water For Injection (WFI)unmatched
  • Work Breakdown Structure (WBS)unmatched

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