6505 - Validation Engineer / CQV Engineer - Change Control & Deviations

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 and CQV lifecycle support within pharmaceutical or medical device manufacturing.

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 (Scientists, Quality) to ensure timely and compliant change implementation; Support execution of change control deliverables, which could include tracking/updating to documentation; Analytical Development; Maintain 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 SME support 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

Requirements

Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related field; 1-3 years of experience in CQV, Validation, or Quality Engineering in a regulated industry; Strong experience with change control systems; Strong experience with cGMP and GDP environments; Strong technical writing and documentation skills; Excellent communication and cross-functional collaboration abilities; Onsite job requirement in Indianapolis, IN

Nice to have

Familiarity with analytical testing and Chemistry is highly preferred; Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus

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