Computer System Validation Quality Specialist

Job Description

Job Description
JOB SUMMARYComputer System Validation Quality Specialist is responsible for reviewing and approving CSV lifecycle documentation and ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity principles. Provides quality oversight for manufacturing and utilities systems, supports regulatory inspections, and collaborates cross-functionally to enable compliant, efficient project execution. Acts as a quality reviewer for digital systems and platforms, ensuring proper configuration, data integrity, and segregation of GxP vs non-GxP use cases.
KEY RESPONSIBILITIES

• Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports)
• Ensure risk-based validation approaches aligned with regulatory standards
• Evaluate system changes through change control, assessing GxP impact and validation requirements
• Support periodic reviews and re-validation activities
• Act as Quality reviewer/approver for MES/EBR platforms, historians, analytics tools, and lab systems
• Review configurations for data acquisition, audit trails, access control, and electronic records/signatures
• Assess and approve data flows, interfaces, and integrations between systems
• Support regulatory inspections (FDA, EMA) and internal audits
• Collaborate with Engineering, Automation, IT, and Operations to enable compliant validation strategies
• Provide Quality input during project design, FAT/SAT, and commissioning phases

REQUIRED QUALIFICATIONS

• Master’s degree in Engineering, Computer Science, Life Sciences, or related field
• 3–5 years of experience in pharmaceutical or regulated manufacturing, with at least 2 years in a quality organization
• 3+ years of hands-on CSV experience reviewing and approving validation documentation
• Direct experience supporting manufacturing or utilities systems
• Strong knowledge of CSV lifecycle, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity (ALCOA+)
• Practical experience with MES/EBR systems, process historians, and advanced analytics platforms
• Familiarity with change control, deviations, and CAPA systems

PREFERRED QUALIFICATIONS

• Experience with Werum PAS-X, Seeq, PI Vision, Power BI
• Agile or lean validation approaches
• Commissioning & Qualification (C&Q) integration with CSV
• Prior involvement in FDA inspections related to computerized systems
• Experience with site digitalization or Industry 4.0 initiatives

KEY COMPETENCIES

• Risk-based decision making with compliance focus
• Strong documentation review and technical writing skills
• Ability to challenge constructively while remaining solution-oriented
• Comfortable working at the intersection of Quality, Engineering, and IT
• Pragmatic mindset: compliant yet business-enabling

YEARS OF EXPERIENCE REQUIRED3–5 years in pharmaceutical or regulated manufacturing, with CSV and quality experience

Education: Masters Degree

Company DescriptionCompunnel Inc., established in 1994; is a leading provider of Staffing, IT/Software, e-Learning/Training, Business Intelligence, and Cloud Solutions. A leader in contingent and permanent workforce solutions, we also provide temp-to-hire staffing, project-based/SOW staffing, and payroll services to our esteemed clientele which includes Fortune 500 companies of diverse industry segments. Ranked as one of the largest staffing firms in the US which is our primary service market; we also have a significant presence in Europe and Asia. As a national service provider in the US, we are serving our customers all major states and regions; thereby generating numerous job opportunities for prospective employees in their preferred locations of choice.

We have witnessed multi-fold YOY growth, and continuously adding a large pool of talented resources to our employee base every year. Our extensive experience in hiring professionals of multiple in-demand skill sets (IT, Engineering, Healthcare, Admin-Clerical, Finance, Professional, Light Industrial, etc.) further makes Compunnel a wider and preferred platform for people to pursue their careers in the US. We welcome people from all walks of life and cultures, and we support workforce diversity by providing equal employment opportunities to people without any discrimination based on race, color, gender, religion, national/ethnic region, disability, or any other basis.

Company Description

Compunnel Inc., established in 1994; is a leading provider of Staffing, IT/Software, e-Learning/Training, Business Intelligence, and Cloud Solutions. A leader in contingent and permanent workforce solutions, we also provide temp-to-hire staffing, project-based/SOW staffing, and payroll services to our esteemed clientele which includes Fortune 500 companies of diverse industry segments. Ranked as one of the largest staffing firms in the US which is our primary service market; we also have a significant presence in Europe and Asia. As a national service provider in the US, we are serving our customers all major states and regions; thereby generating numerous job opportunities for prospective employees in their preferred locations of choice.\r\n\r\nWe have witnessed multi-fold YOY growth, and continuously adding a large pool of talented resources to our employee base every year. Our extensive experience in hiring professionals of multiple in-demand skill sets (IT, Engineering, Healthcare, Admin-Clerical, Finance, Professional, Light Industrial, etc.) further makes Compunnel a wider and preferred platform for people to pursue their careers in the US. We welcome people from all walks of life and cultures, and we support workforce diversity by providing equal employment opportunities to people without any discrimination based on race, color, gender, religion, national/ethnic region, disability, or any other basis.