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Project Manager Biotech CQV

ZipRecruiter, Indianapolis, Indiana, us, 46262

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Job DescriptionJob 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

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 .

Excellent leadership, communication, and problem-solving skills.