Pharmaceutical Validation Expert

3 weeks ago


North East, United Kingdom AMARIS GROUP SA Full time
Job Description

We are seeking a highly skilled CQV Engineer to join our quality and validation team. The successful candidate will work on a significant project in 2025, focusing on facility extension, new equipment installation, and production scale-up in the pharmaceutical industry.

The role is hybrid, based in Durham, USA, and involves leading commissioning, qualification, and validation activities for equipment and systems. This includes developing, reviewing, and approving validation protocols (IQ/OQ/PQ) and related documentation.

The ideal candidate will ensure compliance with FDA regulations and GMP standards across all validation processes. They will conduct risk assessments, gap analyses, and remediation activities for validation procedures.

A strong understanding of FDA regulations, GMP, and validation best practices is essential. Experience with tech transfer, process validation, and facility expansion projects is preferred.

We offer a competitive salary of $120,000 - $150,000 per year, depending on experience. Our benefits package includes health insurance, retirement plan, and paid time off.



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