CQV Engineer for GMP Validation in Life Sciences

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

Benefits offered by this job

Health insurance

Life Insurance

Disability Insurance

HSA

Paid time off

Holidays

Tuition reimbursement

Parental leave

Job summary

Verista, Inc. in Indianapolis, IN seeks a qualification/commissioning engineer to author and execute validation documentation for complex automated equipment and facilities. You will review P&IDs, coordinate with quality representatives, and ensure qualification deliverables meet GMP and FDA standards.

The role involves working on large capital projects, with emphasis on FAT/IQ/OQ/PQ and turnover documentation for validated systems.

Qualifications

• Bachelor’s degree in engineering or science.
• 1–3 years GMP experience.
• Experience with automated manufacturing equipment and packaging.
• Experience authoring/executing validation documents (FAT/IQ/OQ/PQ).
• Knowledge of FDA, ISPE, ISO GDP standards.
• ASTM-E2500 knowledge.

Responsibilities

• Author and execute CQV documentation for equipment and facilities.
• Review P&IDs and electrical schematics.
• Coordinate with client quality reps on deviations and investigations.
• Maintain records of qualification and change control for audits.
• Deliver turnover documentation per client standards.

Skills

GMP experience

FDA regulations

Qualification docs

Automated equipment

Risk assessment

Education

Bachelor’s degree in Engineering or Scientific field

Tools

P&IDs review

Job description

Verista, Inc. in Indianapolis, IN seeks a qualification/commissioning engineer to author and execute validation documentation for complex automated equipment and facilities. You will review P&IDs, coordinate with quality representatives, and ensure qualification deliverables meet GMP and FDA standards.

The role involves working on large capital projects, with emphasis on FAT/IQ/OQ/PQ and turnover documentation for validated systems.