Job description
Mission Overview
Join Amaris and support one of our key pharmaceutical clients as a Validation Specialist focused on ensuring compliance and operational excellence in Quality Control (QC) and Manufacturing. You will play a critical role in delivering high-quality, cGMP-compliant validation activities for small-scale equipment and associated software systems.
This is a hands-on, technical role offering direct impact on product quality and regulatory compliance within a dynamic, international environment.
Key Responsibilities
* Develop, implement, and execute URS, CAT, SIA, DQ, IQ, OQ, PQ, RV, and TM protocols for small-scale equipment in QC and Manufacturing, including embedded software.
* Lead validation studies for cGMP-critical process systems to ensure compliance with regulatory, user, and company requirements.
* Perform system qualifications where industry precedents exist but require site- or case-specific interpretation.
* Ensure continuous compliance with cGMP, cGLP, internal procedures throughout the equipment lifecycle.
* Support cross-functional projects while adhering to all applicable regulatory standards (FDA, EU).
* Maintain up-to-date knowledge of evolving validation regulations and industry best practices; provide expert input on US FDA and EU compliance requirements.
* Take full ownership of validation documentation from drafting through approval and implementation.
* Evaluate change controls and deviations to determine impact on validated state and documentation.
Required Skills & Experience
* 2–4 years of experience in a pharmaceutical, biotech, or healthcare manufacturing environment.
* Proven experience in qualification of small-scale equipment (e.g., balances, pH meters, centrifuges) and associated software.
* Solid understanding of cGMP, quality management systems (QMS), and compliance regulations.
* Ability to troubleshoot validation issues and propose effective, compliant solutions.
* Strong documentation skills with attention to detail and accuracy.
* Proactive mindset, able to work independently and collaboratively in a regulated environment.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.