Skills

Communication Test Technical Writing Attention to detail Effective Communication Organizational Skills

Job Specifications

Location: Belgium, Brussels

Employment Type: Contract / Full-time

Duration: Long-term project

Project Overview:

We are seeking a skilled professional to support a project focused on documenting and validating software installed on lab instrumentation in line with the new EMA guidelines. The role also involves migrating software management to PPD IT software management SOPs while ensuring compliance with GxP and GAMP5 standards.

Key Responsibilities:

Document and validate software installed on laboratory instrumentation according to EMA guidelines.
Migrate the management of instrument software to PPD IT software management SOPs.
Gather, analyze, and document system and user requirements.
Write and maintain validation test cases in alignment with CSV practices.
Document software specifications and configurations of current systems.
Create and maintain infrastructure and data flow diagrams.
Perform and document risk assessments for validated systems.
Collaborate with cross-functional teams (IT, QA, Lab Operations) to ensure compliance and accurate documentation.

Required Skills & Qualifications:

Proven experience in Computerized System Validation (CSV) and Software Validation within regulated environments.
Strong knowledge of EMA, GxP, and GAMP5 guidelines.
Excellent technical writing and documentation skills.
Ability to perform risk assessments for laboratory and IT systems.
Strong attention to detail and organizational skills.
Effective communication and collaboration skills.

Preferred Qualifications (Nice to Have):

Previous experience working with lab instrumentation software in a regulated environment.
Familiarity with PPD IT systems, SOPs, or similar IT governance frameworks.
Experience in pharmaceutical/biotech / CRO industries.

Why Join Us?

Opportunity to work on a high-impact project ensuring compliance with the latest EMA regulatory guidelines.
Collaborate with global teams in a science-driven, regulated environment.
Gain hands-on experience with lab software validation and regulatory compliance.

We're grateful for your interest in joining our team. Kindly note that only applicants whose experience and qualifications most closely align with the role will be contacted for the next steps. Thank you for your understanding.

About the Company

UST is a global digital transformation solutions provider. For more than 20 years, UST has worked side by side with the world's best companies to make a real impact through transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design to operation. With deep domain expertise and a future-proof philosophy, UST embeds innovation and agility into their clients' organizations. With over 29K+ employees in 30 countries, UST builds for boundless impact--touching billions o... Know more