6590 - CQV Engineer - Change Control & Deviations

We are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

The ideal candidate will have hands-on experience in change management and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Validation Engineer / CQV Engineer Responsibilities:

Change Control Management

• Author, review, and manage change controls impacting systems, equipment, and processes
• Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact
• Collaborate with cross-functional teams (Scientists, Quality) to ensure timely and compliant change implementation
• Support execution of change control deliverables, which could include tracking/ updating to  documentation

CQV & Compliance Support

• Analytical Development
• Maintain alignment with cGMP and Good Documentation Practices (GDP)
• Support impact assessments and execution activities related to changes
• Review and approve technical documentation as required
• Participate in audits and inspections, providing SME support for change control and deviation processes

Cross-Functional Collaboration

• Interface with Analytics, Quality Assurance, , and Engineering teams 
• Support continuous improvement initiatives related to quality systems and CQV processes
• Communicate project status, risks, and issues to stakeholders

Requirements:

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related field
• 1-3 years of experience in CQV, Validation, or Quality Engineering in a regulated industry - Entry-level candidates encouraged to apply
• Strong experience with:
• Change control systems
• cGMP and GDP environments
• Familiarity with analytical testing and Chemistry  is highly preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities
• Onsite job requirement in Indianapolis, IN