Project Engineer, Quality Engineering

Account Manager - Client Services at Brightpath Associates

About the job

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. Get 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

• 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 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 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 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.
• 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.

Seniority level:
Mid-Senior level

Employment type:

Full‑time