GMP Pros, Inc.
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. 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.
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, 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 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 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, 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.
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, with experience in 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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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. 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.
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, 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 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 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, 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.
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, with experience in 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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