6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2

Senior CSV/CQV Engineer / Senior Validation Engineer 2

Durham, NC

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Position Summary

The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities, and PAT systems. This role is responsible for all computerized system validation (CSV) and data integrity (DI) activities, working under the direction of the Validation Lead and alongside the CQV team.

General CSV Skills

• Familiarity with global standards for computerized systems and data integrity.
• Ability to classify systems as "simple" or "complex" using risk‑based criteria to right‑size validation effort.
• Experience authoring CSV deliverables: URS/FDS/DDS review, risk assessments, test protocols (IQ/OQ), and summary reports.
• Supplier assessment execution for OEM‑provided computerized systems.
• Data integrity assessment using ALCOA+ principles, including audit trail, user roles, time sync (NTP), backup/restore, and archival.

Project‑Specific CSV Responsibilities

CSV Deliverables

• Author Data Integrity Assessments for each Direct Impact computerized system, defining roles/privileges, and confirming electronic records handling.
• Assess and document how PAT result data integrates with the paper‑based manufacturing batch record (MBR) interface, ensuring data integrity at the point of data transfer.
• Perform supplier assessments for major OEM systems and PAT instruments.
• Author configuration specifications for computerized systems where client templates are available or where vendor documentation is insufficient.
• Write CSV sections within IQ/OQ protocols – access control, audit trail verification, time sync (NTP), backup/restore, and data flow tests.
• Develop data flow diagrams for critical integrations:

• Execute IQ/OQ CSV test scripts, including; User role and access control, Audit trail review, Time synchronization, Backup and restore, and Data flow and accuracy
• PAT integration testing
• Document any deviations discovered during CSV testing, perform impact assessment, and track CAPAs to closure.

Required Qualifications

• Bachelor's degree in engineering, computer science, or related field.
• Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments.
• Proven experience with equipment‑level PLC/HMI validation (OEM systems) and historian connectivity.
• Hands‑on experience with PAT instrument integration (e.g., NIR, moisture analyzers) is a strong plus.
• Must be local in or around RTP, must be able to work on site 100%.

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. *Verista is an equal opportunity employer.

National (US) Range

$65,000 - $90,817 USD

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement