A leading life sciences organization is seeking a Senior Validation Engineer to oversee the lifecycle of computer systems and software validation. The role is centered on creating a comprehensive validation master file, ensuring all software and equipment align with international quality standards and federal regulations. This is an on-site position requiring a candidate with deep expertise in software assurance and process qualification.

Principal Duties & Responsibilities

• Design and execute validation protocols for both off-the-shelf and custom-built software, ensuring compliance with the latest industry-standard software assurance guidelines.

• Lead the qualification of internal equipment and manufacturing processes, including those transferred to external partners.

• Author and manage a complete suite of validation documentation, including process maps, risk assessments, test protocols, and summary reports.

• Support the quality team in managing system changes and maintaining the integrity of the Quality Management System.

• Collaborate with cross-functional departments to ensure all technical processes meet rigorous safety and performance requirements.

Required Skills & Qualifications

• Advanced degree (BSc, MSc, or PhD) in Engineering or a related technical science.

• Significant tenure (5+ years) in the medical technology sector within environments governed by ISO 13485 or 21 CFR 820.

• Extensive experience specifically in Computer System Validation (CSV) and software lifecycle management.

• Exceptional technical writing skills with the ability to translate complex processes into clear, documented requirements.

• Proven ability to manage multiple high-priority projects independently in a fast-paced setting.

• A self-directed professional with strong decision-making skills and a high degree of attention to detail.

Desired Skills and Qualifications

• Hands-on experience with technical measurement equipment and methodologies.

• Proficiency in advanced project management software and data tracking tools.

• Familiarity with risk-based approaches to validation and process optimization.