GMP Pros®
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Project Engineer (Facilities) - 1099
role at
GMP Pros®
We are seeking a solutions- and process-oriented Project Engineer to support Capital Projects for a key client. Be part of an exciting start-up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. Attain the best of both worlds: experience at a company that leads projects for global pharmaceutical companies with the flexibility and personal attention found in a small, close-knit team.
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 Closeout)
Develop comprehensive project documentation, including scope, schedule, WBS, and budget
Create and develop documentation across the project lifecycle as needed, including 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 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, and negotiating with suppliers/vendors
Identify, procure, and manage vendors and subcontractors
Perform and support feasibility studies for new packaging lines
Ensure compliance with relevant requirements (e.g., 21 CFR, GxP, OSHA, APHIS, USP, EHS, client 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
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 in using 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
Excellent communication and organizational 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
Job details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
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Project Engineer (Facilities) - 1099
role at
GMP Pros®
We are seeking a solutions- and process-oriented Project Engineer to support Capital Projects for a key client. Be part of an exciting start-up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. Attain the best of both worlds: experience at a company that leads projects for global pharmaceutical companies with the flexibility and personal attention found in a small, close-knit team.
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 Closeout)
Develop comprehensive project documentation, including scope, schedule, WBS, and budget
Create and develop documentation across the project lifecycle as needed, including 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 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, and negotiating with suppliers/vendors
Identify, procure, and manage vendors and subcontractors
Perform and support feasibility studies for new packaging lines
Ensure compliance with relevant requirements (e.g., 21 CFR, GxP, OSHA, APHIS, USP, EHS, client 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
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 in using 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
Excellent communication and organizational 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
Job details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
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