Systems Validation Specialist II

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are seeking a System Validation Specialist to join our SVS team. This role will support and improve the compliance of our technology solutions by implementing standardized, harmonized, and streamlined validation/qualification activities based on current GxP requirements and risk management principles.

Key Responsibilities:

Validation Representative

• Lead specific tasks in executing Parexel's system validation strategy.
• Plan and oversee risk-based approaches to system validation.
• Provide validation consultancy and guidance to ensure regulatory compliance.
• Conduct periodic reviews to verify the maintained validated state of technology solutions.
• Support risk management activities to identify, assess, and control technology-related risks.
• Assist with audit/inspection preparation and support.
• Contribute to data collection and review of Requests For Information (RFI).

Standards & Quality Framework

• Assist Process Owners and Stakeholders in developing and maintaining Validation Framework Controlled Documents.
• Contribute to the development and maintenance of Managed Information supporting the Validation Framework.
• Help develop and deliver training materials for the Validation Framework.

Required Skills:

• Entry to mid-level experience in computer technology quality and compliance, including computerized system validation.
• Basic knowledge of continuous improvement methodologies.
• Competency in core project management activities.
• Excellent interpersonal, verbal, and written communication skills.
• Strong organizational and prioritization abilities.
• Ability to work in a fast-paced, customer-focused environment.
• Self-motivated with a desire for professional development.
• Cultural awareness and ability to think and work globally.
• Intermediate proficiency in desktop software (MS Office, Excel, Adobe PDF, etc.)

Knowledge and Experience:

• 3+ years of experience in clinical trials and/or clinical research, with emphasis on GCP and technology compliance.
• Familiarity with technology related to clinical trial activities, including System Life Cycle processes and applicable GCP regulations.
• Entry-level knowledge of project management, Lean Six-Sigma, auditing, and/or risk management methodologies.

Education:

• Bachelor's degree in technology, biological science, pharmacy, or other health-related discipline preferred.
• Equivalent qualification or 3+ years of clinical research experience will be considered.
• Good English skills.