OT - Validation Engineer GXP systems, Geleen

Junior/Intermediate CSV Specialist (GxP Systems) Location: Geleen

Industry: Pharmaceutical / Biotechnology

Job Description Summary We are currently seeking a Junior to Intermediate CSV Specialist to support and maintain the quality and validation of computerized systems within a GMP-regulated environment. This role focuses on ensuring compliance, system reliability, and effective support for laboratory software and infrastructure.

Key Responsibilities

Administer GxP computerized lab systems, including installation, backup, archiving, and data management

Support validation activities for computerized systems, including writing and reviewing validation protocols and reports (IQ/OQ/PQ)

Assist in the implementation of new systems and software

Provide day-to-day support to end users and troubleshoot system-related issues

Manage and coordinate deviations, change controls, and corrective actions

Ensure compliance with internal procedures and regulatory requirements

Collaborate with internal stakeholders to optimize system usage

Support audits and ensure proper follow-up on CAPAs

Contribute to change management processes for system updates and new implementations

Maintain knowledge of evolving technologies and their application

Profile

Bachelor’s degree in a scientific or technical field

Experience or strong interest in computerized systems validation (CSV)

Familiarity with GMP, GAMP, and data integrity principles

Understanding of validation practices (IQ/OQ/PQ)

Strong technical writing and documentation skills

Good communication and organizational abilities

Ability to work independently and in a team-oriented environment

Proactive and adaptable mindset

Strong problem-solving skills and attention to detail

Collaborative and communicative approach

Results-driven with a focus on quality and compliance

Willingness to learn and grow within a regulated environment

What’s Offered

Entry to mid-level opportunity within a highly regulated biotech/pharma environment

Exposure to computerized systems and validation processes

A collaborative and quality-driven work culture

Competitive salary and development opportunities

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