ATL01-052225 Project Manager Biotech CQV (MA)
ATL01-052225 Project Manager Biotech CQV (MA)
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Salary Not Disclosed
1 Vacancy
Job Description
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:
Bachelors 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.
Required Experience:
IC
Employment Type
Contract
