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

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

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

Location

Onsite job requirement in Indianapolis, IN

Compensation

National (US) Range: $59,951 - $102,623 USD

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

Company Culture

We empower and support our colleagues, commit to client success at every turn, have the courage to do the right thing, encourage an inclusive environment where our colleagues feel respected, engaged, and challenged, and constantly acquire new skills and learn from our experiences to enhance our collective expertise.