Atl01 052225 Project Manager Biotech Cqv

Indianapolis, IN, US, United States

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

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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Job Detail

  • Job Id
    JD5480907
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Indianapolis, IN, US, United States
  • Education
    Not mentioned