Job Description

Job Description

Job Title: Process Engineer

Location: Lexington, MA

Duration: February 2026 – December 2028

Commitment: Full-time (40 hours/week) - On-Site with minimal travel

Role Overview

The Process Engineer will support a major capital project involving the design and construction of a new Oral Solid Dosage (OSD) manufacturing facility. Responsibilities include equipment procurement, installation, start-up, and commissioning. The engineer will act as an equipment package owner and serve as the primary technical resource for the project, including assisting with validation activities.

Key Responsibilities

• Collaborate with project stakeholders, equipment vendors, site engineering, and automation teams.
• Develop equipment bid packages (URS, data sheets, specifications).
• Manage equipment purchasing activities from procurement through delivery.
• Support facility design and construction activities.
• Participate in the equipment CQV lifecycle:
• Conduct design reviews and risk assessments.
• Create and execute commissioning protocols.
• Support validation protocol approval and execution.
• Maintain required training and contribute to documentation and protocol development.
• Travel to vendor locations as needed for project activities.

Required Experience

• Extensive experience in an OSD cGMP environment.
• Proven project delivery experience with: Isolators, Downflow booths, Material handling systems (powder-related)
• Experience with at least one of the following: Granulation systems (wet and dry), Tablet compression systems, Tablet coaters, Packaging lines (primary and secondary)

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