Project Engineer; Facilities

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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.

• 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

• 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

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Engineering and Information Technology