6321 - Validation Engineer / CQV Engineer - Change Control & Deviations

Verista•Indianapolis, IN

2d•Onsite

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise 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, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related field
3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industry
Strong experience with: Change control systems
Deviation investigations and root cause analysis
cGMP and GDP environments
Familiarity with device assembly/packaging operations 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

Responsibilities

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 (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementation
Support execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)
Lead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)
Ensure deviations are thoroughly documented, investigated, and closed within required timelines
Partner with Quality teams to ensure compliance with internal procedures and regulatory expectations
Maintain alignment with cGMP and Good Documentation Practices (GDP)
Support validation impact assessments and execution activities related to changes
Review and approve validation and technical documentation as required
Participate in audits and inspections, providing SME support for change control and deviation processes
Interface with Manufacturing, Quality Assurance, Automation, and Engineering teams
Support continuous improvement initiatives related to quality systems and CQV processes
Communicate project status, risks, and issues to stakeholders