Process Equipment Project Engineer

JOB Description:

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Seeking an experienced Process Equipment Project Engineer to support equipment specification, procurement, and facility integration for a GMP biopharmaceutical manufacturing project. The consultant will review the planned process equipment list and associated technical specifications, identify installation and utility requirements, work with facility engineering to confirm equipment compatibility with the existing manufacturing suite, develop equipment User Requirement Specifications, support technical reviews with internal SMEs, drive portions of the vendor/RFP process, and contribute to preliminary cost, schedule, installation, and CQV planning. The engineer should have hands-on experience managing process equipment through specification and procurement within a regulated pharmaceutical or biologics environment.

Qualifications:

• Bioprocess Equipment: Strong experience with pharmaceutical, biologics, or cell and gene therapy process equipment.
• Equipment Specifications: Ability to review equipment specifications and identify space, utility, installation, operational, and validation requirements.
• URS Development: Demonstrated experience developing User Requirement Specifications for GMP process equipment.
• Equipment Procurement: Experience supporting equipment selection, vendor evaluations, RFQs/RFPs, technical bid reviews, and procurement activities.
• Facility Integration: Experience coordinating equipment installation requirements with Facilities, Utilities, Process Engineering, and Manufacturing.
• GMP Environment: Strong understanding of engineering requirements within regulated pharmaceutical or biologics manufacturing.
• CQV: Understanding of equipment commissioning, qualification, and validation requirements.
• Project Engineering: Ability to coordinate scope, technical requirements, vendors, cost estimates, schedules, and project deliverables.
• Cross-Functional Collaboration: Ability to work directly with Manufacturing, MSAT, Validation, Quality, Facilities, and Engineering stakeholders.
• Independent Execution: Comfortable proactively gathering missing technical information and driving issues to resolution without requiring significant day-to-day direction.

Ideal Candidate Profile:

A senior process equipment or project engineer with direct experience specifying and procuring GMP bioprocess equipment and integrating that equipment into an existing manufacturing facility. xhyhwjd The ideal candidate understands both the equipment and the downstream installation, utility, facility, and CQV implications and can help move the project from preliminary equipment list through a procurement-ready package.