Senior CSV/CQV Engineer — Onsite RTP, Data Integrity

Veristainc; Durham (NC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Competitive pay and performance incentives

Medical, Dental & Vision insurances

401(k) Retirement Plan with Employer Matching

Tuition Reimbursement

Paid Time Off and Holidays

Job summary

Veristainc is looking for a CSV/CQV Engineer in Durham, NC to support commissioning, qualification, and validation of process equipment. The ideal candidate will have over 5 years of experience in CSV, focusing on data integrity and computerized systems.

This role requires a Bachelor's degree in engineering or computer science and expertise in PAT instrument integration. The position offers a comprehensive benefits package including medical insurances and a 401(k) plan.

Qualifications

• Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments.
• Proven experience with equipment-level PLC/HMI validation and historian connectivity.
• Hands-on experience with PAT instrument integration is a strong plus.

Responsibilities

• Support the commissioning, qualification, and validation of process equipment, utilities, and PAT systems.
• Write CSV sections within IQ/OQ protocols including access control and audit trail verification.
• Document deviations during CSV testing and track CAPAs to closure.

Skills

Computerized systems validation

Data integrity assessments

Risk-based validation

Supplier assessment execution

Configuration specifications for computerized systems

Education

Bachelor’s degree in engineering or computer science

Tools

PLC/HMI validation

PAT instruments

Job description

Veristainc is looking for a CSV/CQV Engineer in Durham, NC to support commissioning, qualification, and validation of process equipment. The ideal candidate will have over 5 years of experience in CSV, focusing on data integrity and computerized systems.

This role requires a Bachelor's degree in engineering or computer science and expertise in PAT instrument integration. The position offers a comprehensive benefits package including medical insurances and a 401(k) plan.