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

Verista, Inc. • Indianapolis, IN

13h • Onsite

About The Position

Verista is 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
• Strong experience with deviation investigations and root cause analysis
• Strong experience with cGMP and GDP environments
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities

Nice To Haves

• Familiarity with device assembly/packaging operations is highly preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus

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

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees