What are the responsibilities and job description for the ATL01-052225 Project Manager Biotech CQV position at Validation & Engineering Group?
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
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:
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Oversee the full lifecycle of CQV deliverables including protocol planning, execution, and closure.
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Develop a detailed Gantt chart for protocol development and execution; provide schedule adherence metrics as part of a weekly status report.
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Manage the CQV resource plan and coordinate across Engineering, QA, Operations, and Digital stakeholders.
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Escalate technical and quality-related risks impacting scope, schedule, or budget.
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Lead the resolution of deviations and discrepancies during commissioning and qualification.
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Ensure alignment with corporate standards and best practices throughout C&Q phases.
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Oversee turnover documentation and ensure proper archival of validation records.
Qualifications:
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Bachelors degree in engineering, life sciences, or related field.
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Minimum 10 years of project management experience in GMP manufacturing environments.
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Experience leading commissioning and qualification of drug product manufacturing areas (fill/finish, packaging, utilities, automation).
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Strong working knowledge of cGMPs, FDA/EU regulations, and validation lifecycle.
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Proficiency in project management tools (e.g., MS Project, Excel).
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PMP certification preferred.
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Excellent leadership, communication, and problem-solving skills.
