CQV Engineer — GMP Validation for Life Sciences Equipment

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

Benefits offered by this job

Competitive pay

Health insurance

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Life Insurance

Disability Insurance

Employee Recognition

Job summary

Verista, a leader in life sciences CQV services, seeks a CQV Engineer to deliver commissioning, qualification, and verification on large capital projects. You will author and execute validation documentation, review P&IDs, and work with clients’ quality teams to resolve deviations.

The role requires a bachelor’s degree in engineering or science and 1–3 years in GMP environments, with familiarity of FDA ISPE and GDP standards. US-based compensation is provided with comprehensive benefits.

Qualifications

• Bachelor’s degree in Engineering or Science field
• 1–3 years’ GMP regulated environment experience
• Experience with FAT/IQ/OQ/PQ validation and change controls
• Knowledge of FDA, ISPE guidelines, and ISO GDP in pharma environment
• ASTM-E2500 knowledge

Responsibilities

• Provide technical CQV expertise on large capital projects ensuring CQV deliverables are delivered consistently and efficiently.
• Author and execute commissioning and qualification documents per quality standards (GMP, 21 CFR 210/211/820).
• Verify system drawings, review as-built P&IDs and I&C drawings with electrical support.
• Collaborate with clients’ quality representatives to complete deviation investigations and change control activities.
• Project assignments vary by customer requirements for defined deliverables.

Skills

CQV Experience

GMP Knowledge

Regulatory Knowledge

Automated Equipment

Education

Bachelor’s degree in Engineering or Science

Job description

Verista, a leader in life sciences CQV services, seeks a CQV Engineer to deliver commissioning, qualification, and verification on large capital projects. You will author and execute validation documentation, review P&IDs, and work with clients’ quality teams to resolve deviations.

The role requires a bachelor’s degree in engineering or science and 1–3 years in GMP environments, with familiarity of FDA ISPE and GDP standards. US-based compensation is provided with comprehensive benefits.