Associate CSV – Periodic Review Scientist

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Associate CSV – Periodic Review Scientist

Position Summary

The Associate CSV Periodic Review Scientist supports the execution of periodic reviews for GxP computer systems to ensure compliance with regulatory requirements and maintenance of the validated state. This entry-level role focuses on learning and applying validation principles, supporting risk-based assessments, and developing technical and compliance expertise in a GMP-regulated environment.

Key Responsibilities

• Assist in the execution of Periodic Reviews (PR) for GxP computer systems under supervision.
• Support the evaluation of:
  • Change controls, deviations, and CAPAs
  • System maintenance and calibration status
  • User access reviews and audit trails
  • Backup and restore processes
• Help compile and organize documentation for PR reports.
• Apply basic risk-based thinking to assess system status and identify potential issues.
• Ensure documentation meets GDP (Good Documentation Practices) requirements.
• Collaborate with cross-functional teams such as QA, IT, Engineering, and Operations.
• Support audit and inspection readiness activities.
• Follow procedures aligned with 21 CFR Part 11, EU Annex 11, and Data Integrity requirements.
• Participate in training programs to build knowledge in CSV/CSA and GxP compliance.

Qualifications

• Bachelor’s degree in:
  • Engineering (any discipline)
  • Computer Science / Information Systems
  • Life Sciences (Biology, Chemistry, Microbiology)

• 0–2 years of experience in:
  • GMP environment, validation, IT, or quality (internships or co-ops acceptable)
• Exposure to computer systems or regulated environments is a plus

Technical Skills

• Basic understanding (or willingness to learn):
  • GxP regulations
  • Data Integrity (ALCOA+)
  • CSV/CSA concepts
• Familiarity with:
  • Microsoft Office (Excel, Word, PowerPoint)
• Exposure to GxP systems (SAP, LIMS, etc.) is a plus but not required

Preferred Qualifications

• Internship experience in pharmaceutical, biotech, or regulated industries
• Basic knowledge of validation lifecycle or system documentation
• Exposure to audit or compliance activities

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.