Senior CSV/CQV Engineer – Validation & Data Integrity

Verista; Durham (NC); On-site; USD 65,000 - 90,817; Full time

Benefits offered by this job

High growth potential

Competitive pay

Medical, Dental & Vision insurances

401(k) Retirement Plan

Tuition Reimbursement

Paid Time Off

Job summary

Verista in Durham, North Carolina is seeking a CSV/CQV Engineer to support the commissioning, qualification, and validation of process equipment and utilities. This role requires a Bachelor's degree in engineering and at least 5 years of experience in CSV within pharmaceutical or biotech environments.

The salary for this position ranges from $65,000 to $90,817, depending on qualifications and experience. This position is on-site 100% of the time.

Qualifications

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

Responsibilities

• Support commissioning, qualification, and validation of processes.
• Author Data Integrity Assessments for computerized systems.
• Execute IQ/OQ CSV test scripts.

Skills

Familiarity with global standards for computerized systems and data integrity

Ability to classify systems using risk-based criteria

Experience authoring CSV deliverables

Supplier assessment execution

Data integrity assessment using ALCOA+ principles

Education

Bachelor's degree in engineering, computer science, or related field

Job description

Verista in Durham, North Carolina is seeking a CSV/CQV Engineer to support the commissioning, qualification, and validation of process equipment and utilities. This role requires a Bachelor's degree in engineering and at least 5 years of experience in CSV within pharmaceutical or biotech environments.

The salary for this position ranges from $65,000 to $90,817, depending on qualifications and experience. This position is on-site 100% of the time.