Validation & Engineering Group
ATL01-052225 Project Manager Biotech CQV (MA)
Validation & Engineering Group, Great Barrington, Massachusetts, United States, 01230
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.
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.