Computer System Validation Specialist

iO Associates are delighted to be supporting this CDMO on the appointment of a CSV Specialist. This hire is essential for driving the organization’s strategic initiatives in digital technology and quality management systems. The CSV Specialist will play a pivotal role in assuring that computerized systems meet both compliance and operational standards, contributing significantly to the ongoing success and reliability of the organization’s operations. This is an exciting opportunity to be part of a dynamic IT team and make a meaningful impact.

Responsibilities

• Contribute to risk assessments and management processes.
• Support Quality Management System (QMS) functions, including Deviations, Change Control, and CAPA activities.
• Author, review, and contribute to User Requirements, Configuration, and Functional Specifications.
• Develop and execute Qualification protocols and other testing activities.
• Perform lifecycle tasks such as periodic reviews, change management, and system decommissioning.

Essential Skills & Experience

• Associate’s degree in engineering, biology, computer science, mathematics, or a related discipline.
• Minimum of 2 years in a technical role (Engineering, IT, lab work), or an equivalent combination of education and experience.
• Experience in Validation, GxP quality systems, software quality, bio-manufacturing, or related fields.
• Basic understanding of Good Manufacturing Practices (GMP) regulatory requirements.
• Strong professional communication and technical writing skills.
• Proficiency with computer hardware/software for business functions.

Desirable Skills & Experience

• Familiarity with computerized chemical/biological manufacturing systems, enterprise software platforms (ERP, eQMS, LIMS), or computerized analytical instruments.
• Demonstrated proficiency in science-based critical thinking and risk management.

Get in touch if you would like to apply

*Unfortunately sponsorship is not available for this opportunity and the successful candidate will be full time on site.