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

Veristainc; Indianapolis (IN); On-site; USD 59,951 - 102,623; Full time

Benefits offered by this job

Competitive pay plus performance-based incentives

Medical, Dental & Vision insurances

401(k) Retirement Plan

Tuition Reimbursement

Paid Time Off and Holidays

Job summary

Veristainc is seeking a CQV Engineer in Indianapolis, IN to support compliance and quality systems in a regulated cGMP environment. The chosen candidate will manage change control and deviation investigations, ensuring all processes meet industry standards.

The ideal candidate will possess a Bachelor's degree in Engineering or Life Sciences and have over 3 years of relevant experience in CQV or Quality Engineering. Competitive salary and comprehensive benefits package are offered.

Qualifications

• 3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industry.
• Strong experience with change control systems and deviation investigations.
• Familiarity with device assembly/packaging operations is highly preferred.

Responsibilities

• Author, review, and manage change controls impacting systems, equipment, and processes.
• Lead and support deviation investigations, ensuring thorough documentation.
• Maintain alignment with cGMP and Good Documentation Practices.

Skills

Change control systems

Deviation investigations

Root cause analysis

cGMP environments

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Job description

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, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Change Control Management

• 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)

Deviation Management

• 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

CQV & Compliance Support

• 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

Cross-Functional Collaboration

• 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
• Onsite job requirement in Indianapolis, IN

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
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Salary: $59,951 – $102,623 USD

*Verista is an equal opportunity employer.