CQV Engineer: GMP Validation for Life Sciences

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

Benefits offered by this job

Health Insurance

Paid Time Off

Tuition Reimbursement

Disability Insurance

Life Insurance

Holidays

Employee Referral Program

Parental Leave & Bereavement

Job summary

Verista in Indianapolis, IN is seeking engineers and QA professionals to support validation of automated equipment in GMP manufacturing environments. You will author, edit, and execute IQ/OQ/PQ protocols, risk assessments, and change controls for complex systems.

Candidates should have a Bachelor's in Engineering or a related field and 1–3 years of GMP experience; familiarity with FAT, IQ, OQ, PQ, and P&ID drawings is preferred.

Qualifications

• Bachelor's degree in engineering or science.
• 1–3 years' experience in GMP environments.
• Experience with automated equipment for manufacturing and packaging.
• Direct experience authoring/edtinging/ executing validation documents (FAT/IQ/OQ/PQ).
• Knowledge of FDA regulations, ISPE guidelines and GDP in pharma.

Responsibilities

• Author and execute validation documentation for equipment, facilities and utilities (FAT, IQ, OQ, PQ).
• Review system drawings including P&IDs and I&C diagrams with engineering support.
• Maintain detailed records of qualification and change control activities for audits.
• Collaborate with clients' QA to address deviations and investigations.

Skills

Automated manufacturing equipment

GMP environment experience

FDA regulations knowledge

Quality documentation

Education

Bachelor's degree in Engineering or Science

Tools

Validation documentation

Job description

Verista in Indianapolis, IN is seeking engineers and QA professionals to support validation of automated equipment in GMP manufacturing environments. You will author, edit, and execute IQ/OQ/PQ protocols, risk assessments, and change controls for complex systems.

Candidates should have a Bachelor's in Engineering or a related field and 1–3 years of GMP experience; familiarity with FAT, IQ, OQ, PQ, and P&ID drawings is preferred.