6590 - CQV Engineer - Change Control & Deviations

Verista • Indianapolis, IN

1d • Onsite

About The Position

Verista is seeking a CQV Engineer to support change control and deviation management in a regulated cGMP environment. The role helps maintain compliance and quality systems, ensuring manufacturing changes are properly assessed, documented, and implemented. The ideal candidate has hands-on experience in change management and CQV lifecycle support within pharmaceutical or medical device manufacturing. This is an onsite position in Indianapolis, Indiana.

The engineer authors, reviews, and manages change controls affecting systems, equipment, and processes; assesses impacts on product quality, the validated state, and regulatory requirements; and collaborates with cross-functional teams to implement changes compliantly and on time. The role also supports Analytical Development, validation lifecycle activities, technical documentation, audits, inspections, and continuous improvement of quality systems and CQV processes.

Verista describes its culture as people-focused, collaborative, inclusive, and committed to client success, ethical conduct, and continuous learning. The listed U.S. salary range is $69,300–$102,623, with actual compensation dependent on job-related factors.

Requirements

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related field.
• 1–3 years of experience in CQV, Validation, or Quality Engineering in a regulated industry; entry-level candidates are encouraged to apply.
• Strong experience with change control systems.
• Strong experience in cGMP and GDP environments.
• Strong technical writing and documentation skills.
• Excellent communication and cross-functional collaboration abilities.

Nice To Haves

• Familiarity with analytical testing and Chemistry is highly preferred.
• Experience supporting validation lifecycle activities, including IQ/OQ/PQ, is a plus.

Responsibilities

• Author, review, and manage change controls affecting systems, equipment, and processes.
• Conduct impact assessments, including evaluation of product quality, validated state, and regulatory impact.
• Collaborate with cross-functional teams, including scientists and Quality, to support timely and compliant change implementation.
• Support execution of change control deliverables, which may include tracking and updating documentation.
• Support Analytical Development while maintaining 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 subject-matter expertise for change control and deviation processes.
• 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.

Benefits

• Competitive pay and performance-based incentive programs.
• Company-paid life, short-term disability, and long-term disability insurance.
• Medical, dental, and vision insurance.
• FSA, DCARE, and commuter benefits.
• Supplemental life, hospital, critical illness, and legal insurance.
• Health Savings Account.
• 401(k) retirement plan with employer matching.
• Paid time off with rollover option and holidays.
• As-needed sick time.
• Tuition reimbursement.
• Team social activities.
• Employee recognition.
• Employee referral program.
• Paid parental leave and bereavement.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level