Pharma CSV Specialist – Validation & Data Integrity

Vance Airscoop; Wilmington (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Subsidized childcare

Career advancement opportunities

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a Computer System Validation Specialist to lead validation projects across laboratory instruments and systems in a GxP environment. You will author validation documentation, execute test scripts, and ensure data integrity in accordance with ISPE GAMP 5 guidelines.

The role requires 2 years of relevant CS Validation experience, strong documentation skills, and the ability to work with internal teams and vendors.

Qualifications

• Two years of experience with Computer System Validation in a GxP environment.
• Experience in writing computer system test scripts, validation protocols and summary reports.
• Knowledge of regulatory requirements (21 CFR Part 11) and data integrity guidance.
• Ability to analyze, troubleshoot, and implement solutions.
• Capability to manage multiple sub-projects and collaborate cross-functionally.

Responsibilities

• Performs and leads computer system validation projects including documentation such as Validation Plans, IQ/OQ/PQ, test scripts, RTM, and data integrity assessments.
• Track and resolve deviations/exceptions during qualification activities.
• Collaborate with management on changes and upgrades to computer systems.
• Coordinate with vendors for equipment/software upgrades and review protocols.
• Communicate validation approaches during audits and review systems for enhancements.

Skills

Computer System Validation

Documentation Writing

Analytical thinking

Communication skills

Project multitasking

Education

Advanced degree in Chemistry or related science

Tools

LabWare LIMS

Job description

Quality Chemical Laboratories (QCL) in Wilmington, NC is seeking a Computer System Validation Specialist to lead validation projects across laboratory instruments and systems in a GxP environment. You will author validation documentation, execute test scripts, and ensure data integrity in accordance with ISPE GAMP 5 guidelines.

The role requires 2 years of relevant CS Validation experience, strong documentation skills, and the ability to work with internal teams and vendors.