We are seeking a Senior Systems Validation Analyst to ensure compliance with GxP (Good Practice) regulations for enterprise business and IT systems in the pharmaceutical and medical device industries. This role is critical in maintaining the integrity, reliability, and quality of data and processes that impact product safety, efficacy, and regulatory compliance.

• Play a key role in ensuring regulatory compliance and product quality.
• Work in a high-impact, innovation-driven environment.
• Collaborate with cross-functional teams in a leading pharmaceutical/medical device organization.

What will you do?

• Develop & Execute Validation Strategies for computerized systems, IT infrastructure, and GxP processes.
• Create & Maintain Documentation (validation plans, risk assessments, test protocols, and reports) aligned with FDA, EMA, ICH, and cGMP regulations.
• Perform Validation Protocol Execution and manage deviation mitigation/remediation activities.
• Assess Change Control Requests to ensure validation compliance.
• Collaborate with QA Teams to uphold validation integrity and regulatory compliance.
• Apply Risk Management Principles to mitigate potential validation risks.
• Train & Support Teams on validation requirements and best practices.
• Support Internal & External Audits related to validation activities.

How will you get here?

Required: 

• Bachelor’s Degree in IT, Biology, Chemistry, Pharmacy, Engineering, or a related field.
• 5+ years of experience in validation within pharmaceuticals, biotech, or medical devices.
  Strong understanding of GxP regulations (GMP, GLP, GCP) and regulatory guidelines (FDA, EMA, ICH).
• Experience with validation methodologies, risk-based validation, and computerized systems validation (CSV).
• Proficiency in document management, change control, and lifecycle management systems.
• Strong analytical, organizational, and communication skills.
• Self-motivated, results-driven, and able to work independently.

Preferred Skills:

• Certified Validation Professional or equivalent work experience.
• Experience with CSA validation processes.
• Knowledge of Quality Management Systems (QMS) and best practices.
• Familiarity with Oracle Cloud SCM and Veeva Vaults.