6187 - Validation Engineer / CQV Engineer - Change Management Focus

Location: Indianapolis, IN

Department: CQV Manufacturing

Verista is seeking a detail-oriented Validation / CQV Engineer with strong experience in change management and documentation control within regulated pharmaceutical manufacturing environments. This role supports commissioning, qualification, validation, and lifecycle change activities to ensure systems, equipment, and processes meet GMP, regulatory, and client requirements.  The ideal candidate brings hands-on experience managing validation documentation, coordinating cross-functional stakeholders, and leading change control activities to support compliant and efficient project execution.

Validation Engineer / CQV Engineer Responsibilities:

Validation & CQV Execution

• Support commissioning, qualification, and validation (CQV) activities for laboratory and manufacturing systems within GMP environments
• Prepare, review, and route validation deliverables including protocols, reports, assessments, and supporting documentation
• Ensure validation documentation is accurate, complete, traceable, and compliant with regulatory and client standards
• Apply Good Documentation Practices (GDP) in authoring, reviewing, and maintaining validation records

Change Management & Change Control

• Lead and support change control processes associated with validated systems, equipment, and procedures
• Coordinate the end-to-end change lifecycle, ensuring impacts are properly assessed, documented, and approved
• Act as a liaison between Quality, Engineering, Manufacturing, and client stakeholders to communicate changes effectively
• Ensure changes are seamlessly integrated into validation strategies, procedures, and controlled documentation

Documentation & Data Integrity

• Manage large volumes of validation documentation, including qualification packages, assessments, and remediation records
• Utilize electronic document management systems (EDMS) and SharePoint to organize, track, and retrieve documentation
• Support data integrity assessments and remediation efforts as required
• Perform final document reviews prior to approval to ensure alignment with internal and client expectations

Cross-Functional Collaboration

• Collaborate with Quality Assurance, Engineering, Manufacturing, and client teams to gather technical input and execute validation strategies
• Provide guidance and support to team members in locating documentation and navigating validation and change processes
• Support project timelines by proactively tracking deliverables, approvals, and dependencies

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
• 2-4 years of experience supporting validation and CQV activities in pharmaceutical or regulated manufacturing environments
• Demonstrated experience with change management and change control processes
• Strong working knowledge of GDP, GMP, and regulatory expectations
• Proficiency with EDMS platforms and Microsoft SharePoint
• Excellent organizational, communication, and problem-solving skills
• Ability to work effectively within cross-functional teams
• Onsite work requirement in Indianapolis, IN