CQV Engineer: Change Control & Deviations (cGMP)

Verista, Inc.; Indianapolis (IN); Sur place; USD 69 000 - 103 000; Plein temps

Avantages offerts par ce poste

Health Savings Account

Paid Time Off

Holidays

Life Insurance

Disability Insurance

Tuition Reimbursement

Parental Leave

Bereavement

Employee Referral Program

Résumé du poste

Verista, Inc. is seeking a CQV Engineer to support change control and deviation management in a regulated cGMP environment at our Indianapolis, IN site. The role requires 1–3 years of CQV/Quality Engineering experience and strong writing and cross-functional collaboration skills.

You will author and review change controls, assess regulatory impact, and coordinate with Scientists, Quality, and Engineering to ensure compliant implementations. Onsite work is required in Indianapolis.

Qualifications

• 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.
• Familiarity with cGMP and GDP environments.
• Onsite job requirement in Indianapolis, IN.
• Excellent communication and cross-functional collaboration abilities.
• Strong technical writing and documentation skills.

Responsabilités

• 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 (Scientists, Quality) to ensure timely and compliant change implementation.
• Support execution of change control deliverables, including updates to documentation.
• Interface with Analytics, Quality Assurance, and Engineering teams to drive improvements.
• Participate in audits and inspections, providing SME support for change control and deviation processes.

Connaissances

Change control systems

cGMP

GDP

Analytical testing

IQ/OQ/PQ

Technical writing

Communication

Cross-functional collaboration

Formation

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

Description du poste

Verista, Inc. is seeking a CQV Engineer to support change control and deviation management in a regulated cGMP environment at our Indianapolis, IN site. The role requires 1–3 years of CQV/Quality Engineering experience and strong writing and cross-functional collaboration skills.

You will author and review change controls, assess regulatory impact, and coordinate with Scientists, Quality, and Engineering to ensure compliant implementations. Onsite work is required in Indianapolis.