Capital Projects Engineer

Job Title: Capital Projects Engineer

Location: Lincoln, NE

Employment Type: Full-Time | On-site | W2/1099

About Firm: 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.

Role Overview: CANDIDATE 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 new packaging lines
• 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

Requirements: 

• Must have experience with Capital projects in Utilities/Facilities (roofing, AHUs, electrical systems, etc.). 
• 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, including experience in one or multiple of the following: Weigh and Dispense, Wet or Dry Granulation, Blending, Compression, Film Coating, Lyophilization, Aseptic Filling, Packaging
• 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