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Project Engineer - W2/1099
role at
GMP Pros®
6 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Do you want to get out of the corporate grind of meetings?
Do you excel at leading large capital projects that require you to be a great planner, negotiator, and change leader?
Are you up to the challenge of leading the transformation of a facility?
This is an opportunity to lead projects for a massive biotech facilities modernization program in the Midwest.
Be part of an exciting start‑up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. 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
Responsibilities
Support capital projects across the project lifecycle (concept to close‑out).
Develop comprehensive project documentation, including scope, schedule, WBS, and budget.
Create and maintain documentation across the project lifecycle as needed, such as 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 the latest CPM 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 escape potential risks, and recommend solutions to mitigate issues.
Support procurement activities, including sourcing materials and equipment, negotiating with suppliers/vendors.
Identify, procure, and manage vendors and subcontractors.
Perform and support feasibility studies for new packaging lines.
Ensure compliance with relevant regulations such as 21 CFR, GxP, OSHA, APHIS, USP, EHS, and client company policies.
Maintain clear communication with vendors, subcontractors, contractors, 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.
Qualifications
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.
Direct experience writing business cases and project proposals to secure funding, including managing the project budget across the lifecycle.
Direct experience sourcing and managing vendors and subcontractors.
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 $5 MM.
Ability to operate under high‑pressure in a timeline‑constrained environment.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Engineering and Information Technology
Referrals increase your chances of interviewing at GMP Pros® by 2x.
Get notified about new Project Engineer jobs in
Lincoln, NE .
#J-18808-Ljbffr
Project Engineer - W2/1099
role at
GMP Pros®
6 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Do you want to get out of the corporate grind of meetings?
Do you excel at leading large capital projects that require you to be a great planner, negotiator, and change leader?
Are you up to the challenge of leading the transformation of a facility?
This is an opportunity to lead projects for a massive biotech facilities modernization program in the Midwest.
Be part of an exciting start‑up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. 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
Responsibilities
Support capital projects across the project lifecycle (concept to close‑out).
Develop comprehensive project documentation, including scope, schedule, WBS, and budget.
Create and maintain documentation across the project lifecycle as needed, such as 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 the latest CPM 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 escape potential risks, and recommend solutions to mitigate issues.
Support procurement activities, including sourcing materials and equipment, negotiating with suppliers/vendors.
Identify, procure, and manage vendors and subcontractors.
Perform and support feasibility studies for new packaging lines.
Ensure compliance with relevant regulations such as 21 CFR, GxP, OSHA, APHIS, USP, EHS, and client company policies.
Maintain clear communication with vendors, subcontractors, contractors, 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.
Qualifications
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.
Direct experience writing business cases and project proposals to secure funding, including managing the project budget across the lifecycle.
Direct experience sourcing and managing vendors and subcontractors.
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 $5 MM.
Ability to operate under high‑pressure in a timeline‑constrained environment.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Engineering and Information Technology
Referrals increase your chances of interviewing at GMP Pros® by 2x.
Get notified about new Project Engineer jobs in
Lincoln, NE .
#J-18808-Ljbffr