Raya Workforce
Job Title:
Capital Projects Engineer
Location:
Lincoln, NE
Employment Type:
Full-Time | On-site | W2/1099
About the Role We are seeking an experienced Capital Projects Engineer to lead and support large‑scale capital projects from concept through closeout within FDA‑regulated industries. The ideal candidate will have strong technical, leadership, and project management experience in pharmaceutical, biotech, or animal health manufacturing environments.
Candidate must have prior experience in biotech, pharmaceutical, or animal health industries to be considered
Key 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 elevate potential risks, and recommend solutions to mitigate issues
Support procurement activities, including sourcing materials and equipment, and negotiate 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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Capital Projects Engineer
Location:
Lincoln, NE
Employment Type:
Full-Time | On-site | W2/1099
About the Role We are seeking an experienced Capital Projects Engineer to lead and support large‑scale capital projects from concept through closeout within FDA‑regulated industries. The ideal candidate will have strong technical, leadership, and project management experience in pharmaceutical, biotech, or animal health manufacturing environments.
Candidate must have prior experience in biotech, pharmaceutical, or animal health industries to be considered
Key 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 elevate potential risks, and recommend solutions to mitigate issues
Support procurement activities, including sourcing materials and equipment, and negotiate 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
#J-18808-Ljbffr