Construction Project Engineer

Job Description

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

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

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 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