Project Engineer

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, 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 escalate potential risks, and recommend solutions to mitigate issues

• Support procurement activities, including sourcing materials and equipment, to include 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

• • 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

• 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 least10 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