QA Operation Engineer

About the role 

We are looking for an excellent QA Operation Engineer to join our team in Israel.

The position is permanent, full time, hybrid.

The QA Operation Engineer will provide quality oversight for GMP operational activities, with a focus on non-conformance management, cleanroom quality support, environmental monitoring activities, quality documentation review, and ECO support.

The role requires a hands-on quality professional with experience in GMP-regulated manufacturing environments, preferably in pharmaceutical, biotech, or medical device operations.

Responsibilities:

• Lead and manage NCMR activities related to materials, products, processes, cleanroom operations, and environmental monitoring events, including containment, investigations, root cause analysis, CAPA follow-up, and effectiveness verification.
• Support cleanroom quality activities, including environmental monitoring, microbial sampling management, contamination control strategy, physical parameter monitoring, excursion follow-up, quality impact evaluation, support cleanroom qualification/requalification activities, including review of protocols, reports, deviations, and related documentation.
• Drive continuous improvement related to cleanroom performance, contamination control, physical parameter stability, monitoring trends, and recurring environmental issues.
• Review quality documentation and support ECO activities related to production, cleanroom operations, engineering, validation, maintenance, warehouse, supply chain, and quality systems.
• Analyze and present quality trends related to environmental monitoring, cleanroom excursions, and QA operational oversight, while supporting compliance with GMP, ISO 13485, FDA QMSR/21 CFR Part 820, internal procedures, and applicable regulatory requirements.

Direct Manager: QA OPS Team Leader

Job Requirements:

• Education:
• BSc in Life Sciences, Biotechnology, Biomedical Engineering, Quality Engineering or similar – must
• CMQ / CQE - an advantage
• Job skills:
• Up to 3 years of experience in QA operations, quality engineering, production quality support, environmental monitoring, or GMP manufacturing support in a pharmaceutical, biotech, or medical device environment – must.
• Experience with cleanroom operations, environmental monitoring, contamination control, NC/NCMR handling, deviation investigations, root cause analysis, CAPA follow-up, and effectiveness verification – strong advantage.
• Good understanding of GMP and quality system principles. Knowledge of ISO 13485 and FDA QMSR/21 CFR Part 820 – advantage.
• Experience with quality documentation review, ECO support, GMP records, SOPs, protocols, reports, and validation-related documentation. 
• Computer skills:
• Full proficiency with Microsoft Office applications.
• Experience with SAP, QMS/eQMS systems, or LIMS – advantage.
• Language skills:
• High-level English writing and verbal communication skills

https://lts.bamboohr.com/careers/129