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Capital Projects Engineer
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Job Title: Capital Projects Engineer
Location: Lincoln, NE
Employment Type: Full-Time | On-site | W2/1099
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
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