Job Title : Validation Specialist & Project Manager

Wilmington, MA (Fully on-site)

Initial 12 Month Contract, W2 ONLY

We’re supporting a growing radiopharmaceutical manufacturing site in Wilmington, MA, seeking a hands-on Validation Specialist & Project Manager to support a major expansion program.

This is a dual-function role combining execution of equipment qualification and validation activities with full ownership of project delivery. You’ll be responsible for writing and executing DQ/IQ/OQ/PQ protocols, managing GMP documentation, and driving the overall project plan, timelines, and cross-functional coordination.

Key responsibilities:

• Execute equipment qualification (DQ/IQ/OQ/PQ) across manufacturing and QC systems.
• Author and manage validation documentation, SOPs, and batch records.
• Support process and method validation activities.
• Own and maintain the project plan (Gantt), milestones, and risk register.
• Drive cross-functional teams to deliver against timelines.
• Provide clear status updates and proactively manage risks.

Requirements:

• 3–7 years’ validation experience in pharma/biopharma environments.
• Strong experience with equipment qualification and GMP documentation.
• Working knowledge of FDA cGMP (21 CFR 210/211).
• Proven project management capability in a technical setting.
• Ability to work independently and drive progress.

Nice to have:

• Radiopharma or sterile manufacturing experience.
• Exposure to analytical equipment qualification.
• PMP or similar project management training.

This is an on-site role, ideal for someone who can balance hands-on validation work with structured project delivery in a fast-paced, regulated environment.

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