6590 - CQV Engineer - Change Control & Deviations
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 support quality systems by ensuring manufacturing changes are assessed, documented, and executed appropriately. The ideal candidate has hands-on experience in change management and CQV lifecycle support within pharmaceutical or medical device manufacturing. The position supports change controls affecting systems, equipment, and processes, including impact assessments of product quality, validated state, and regulatory considerations. It also supports CQV and compliance activities, technical documentation review, audit and inspection readiness, and continuous improvement of quality systems and CQV processes. The role collaborates with Analytics, Quality Assurance, Engineering, and other cross-functional stakeholders. This is an onsite position in Indianapolis, Indiana.
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.
- 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 (IQ/OQ/PQ) is a plus.
Responsibilities
- Author, review, and manage change controls affecting systems, equipment, and processes.
- Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact.
- Collaborate with cross-functional teams to support timely and compliant change implementation.
- Support change-control deliverables, including tracking and updating documentation.
- Support impact assessments and execution activities related to changes.
- Maintain alignment with cGMP and Good Documentation Practices (GDP).
- Review and approve technical documentation as required.
- Participate in audits and inspections, providing subject matter expertise on 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 plus 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
