CQV Engineer: GMP Validation for Life Sciences

Verista, Inc.; Indianapolis (IN); On-site; USD 70,000 - 103,000; Full time

Benefits offered by this job

Company-paid life insurance

Disability insurance

Health Savings Account

Tuition reimbursement

Paid time off and holidays

Employee referral program

Competitive pay with incentives

Job summary

Verista, Inc. in Indianapolis, IN seeks a qualified candidate for CQV-focused validation roles in life sciences. The position requires implementing commissioning, qualification, and verification activities for complex equipment, facilities, and utilities.

Responsibilities include authoring validation documentation, reviewing drawings and control schemes, and coordinating with client QA to close deviations. A GMP background and regulatory knowledge are essential for success in this role.

Qualifications

• Bachelor’s degree in Engineering or Science required.
• 1–3 years’ experience in GMP environment.
• Experience authoring and executing validation documents (FAT/IQ/OQ/PQ).
• Knowledge of FDA regulations, ISPE guidelines, and ISO standards.
• Familiarity with ASTM-E2500 standard.

Responsibilities

• Provide CQV expertise on large capital projects for new or modified equipment, facilities, and utilities.
• Author and execute validation documentation (URS, Risk Assessment, IQ/OQ/PQ, FAT/SAT).
• Review system drawings, P&IDs, I&C drawings, and electrical schematics with engineering support.
• Collaborate with clients’ quality representatives to resolve deviations and maintain records.
• Adapt project assignments to customer requirements and defined deliverables.

Skills

GMP knowledge

Automated equipment

Validation documentation

Regulatory standards

ASTM-E2500

Education

Bachelor's degree in Engineering or Science

Job description

Verista, Inc. in Indianapolis, IN seeks a qualified candidate for CQV-focused validation roles in life sciences. The position requires implementing commissioning, qualification, and verification activities for complex equipment, facilities, and utilities.

Responsibilities include authoring validation documentation, reviewing drawings and control schemes, and coordinating with client QA to close deviations. A GMP background and regulatory knowledge are essential for success in this role.