Description

Manage software validation and compliance activities within a regulated environment, owning the full lifecycle of Computer System Validation (CSV) projects.

This role is on-site.

Responsibilities

• Lead CSV project planning, including the creation and updating of URS, SDS, and RTM documents.
• Create, review, and approve software validation documentation, qualification protocols, and test reports.
• Execute qualification protocols and review software test scripts and code reviews.
• Facilitate change validation as the SQE representative on the Change Control Board.
• Support audit readiness and participate in internal and external audits pertaining to CSV.

Required Skills

• 4-6 years of experience in software quality engineering or computer system validation (CSV).
• Strong experience with Computerized System Development Life Cycle (SDLC) approaches and validation strategies.
• Deep understanding of GxP, data integrity regulations, and 21 CFR Part 11.
• Experience with COTS/Custom made Analytical Instruments and working in QC Laboratories, R&D, or manufacturing.
• Bachelor’s Degree in Engineering, Computer Science, or a related technical field.
• Proven ability to prioritize multiple projects and manage complex validation workflows.
• Strong written and verbal communication skills for coordinating with system administrators and lab managers.

Preferred Skills

• Experience with LIMS, CDS, or Analytical Instrumentation Validation.
• CSQE or CQE certification.
• Knowledge of GAMP5 and bioanalytical workflows.

Key Skills

Education

Any graduate