CQV Validation Engineer - Change Control & Compliance

Verista; Indianapolis (IN); Hybrid; USD 69,000 - 95,000; Full time

Benefits offered by this job

Competitive pay

Company-paid Life Insurance

Disability Insurance

Tuition Reimbursement

Paid Time Off

Health Savings Account

Parental Leave

Job summary

Verista is seeking a CQV Engineer to lead change control management and CQV lifecycle support in a regulated manufacturing setting in Indianapolis, IN. You will author and review change controls, assess product quality impact, and collaborate with Scientists and Quality to ensure timely, compliant implementations.

The role emphasizes cGMP/GDP practices, strong technical writing, and cross‑functional teamwork, with onsite requirements in Indianapolis.

Qualifications

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related field.
• 1-3 years in CQV, Validation, or Quality Engineering in a regulated industry.
• Onsite in Indianapolis, IN.
• Strong technical writing and documentation skills.
• Excellent communication and cross‑functional collaboration abilities.

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, including documentation updates.
• Support validation lifecycle activities (IQ/OQ/PQ) and CQV compliance.

Skills

Change control systems

cGMP / GDP

Technical writing

Cross-functional collaboration

Analytical testing familiarity

Education

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

Tools

IQ/OQ/PQ validation

Job description

Verista is seeking a CQV Engineer to lead change control management and CQV lifecycle support in a regulated manufacturing setting in Indianapolis, IN. You will author and review change controls, assess product quality impact, and collaborate with Scientists and Quality to ensure timely, compliant implementations.

The role emphasizes cGMP/GDP practices, strong technical writing, and cross‑functional teamwork, with onsite requirements in Indianapolis.