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ATL01-052225 Project Manager Biotech CQV (MA)

ATL01-052225 Project Manager Biotech CQV (MA)

Validation & Engineering GroupGreat Barrington, MA, US
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Project Manager

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position :

Project Manager

Location : Norwood, MA

We are currently seeking an experienced Project Manager to lead commissioning and qualification (C&Q) activities for a large-scale GMP facility. The selected candidate must be available to work in production, packaging, and construction areas, in compliance with safety and quality procedures.

Responsibilities :

  • Oversee the full lifecycle of CQV deliverables including protocol planning, execution, and closure.
  • Develop a detailed Gantt chart for protocol development and execution; provide schedule adherence metrics as part of a weekly status report.
  • Manage the CQV resource plan and coordinate across Engineering, QA, Operations, and Digital stakeholders.
  • Escalate technical and quality-related risks impacting scope, schedule, or budget.
  • Lead the resolution of deviations and discrepancies during commissioning and qualification.
  • Ensure alignment with corporate standards and best practices throughout C&Q phases.
  • Oversee turnover documentation and ensure proper archival of validation records.

Qualifications :

  • Bachelor's degree in engineering, life sciences, or related field.
  • Minimum 10 years of project management experience in GMP manufacturing environments.
  • Experience leading commissioning and qualification of drug product manufacturing areas (fill / finish, packaging, utilities, automation).
  • Strong working knowledge of cGMPs, FDA / EU regulations, and validation lifecycle.
  • Proficiency in project management tools (e.g., MS Project, Excel).
  • PMP certification preferred.
  • Excellent leadership, communication, and problem-solving skills.
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    Project Manager • Great Barrington, MA, US