CQV Engineer - GMP Validation for Life Sciences

Veristainc; Indianapolis (IN); On-site; USD 70,000 - 103,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401(k) Matching

Paid Time Off

Tuition Reimbursement

Job summary

Verista is a leading life sciences services firm delivering CQV expertise for large capital projects across biotech and pharma industries. Our team designs and executes commissioning, qualification and verification activities to ensure compliant facilities and equipment.

The role requires a degree in engineering or science and 1–3 years in GMP environments, with hands-on experience in automated equipment and validation documentation such as FAT/IQ/OQ/PQ.

Qualifications

• Bachelor’s degree in Engineering or Scientific field.
• 1–3 years’ experience in GMP regulated environment.
• Experience with automated manufacturing equipment (PLCs, HMIs, PC-based controls).
• Experience authoring/editting/ executing validation documents (FAT, IQ, OQ, PQ).
• Knowledge of FDA regulations, ISPE guidelines and ISO GDP in pharmaceutical environments.

Responsibilities

• Provide CQV expertise on large capital projects including commissioning, qualification and verification.
• Author and execute commissioning and qualification documents per GMP and regulatory standards.
• Review as-built P&IDs and I&C drawings and verify electrical schematics with engineering support.
• Coordinate with client quality reps for deviation investigations and keep detailed records for audits.
• Define deliverables per customer requirements and project scope.

Skills

GMP experience

Quality documentation

Regulatory knowledge

Technical equipment & process

Education

Bachelor’s degree in Engineering or Science

Tools

PLCs

HMIs

PC-based controls

Job description

Verista is a leading life sciences services firm delivering CQV expertise for large capital projects across biotech and pharma industries. Our team designs and executes commissioning, qualification and verification activities to ensure compliant facilities and equipment.

The role requires a degree in engineering or science and 1–3 years in GMP environments, with hands-on experience in automated equipment and validation documentation such as FAT/IQ/OQ/PQ.