EMS Projects Expert – GMP & Quality Lead

Johnson & Johnson Co.; Geel; On-site; EUR 60,000 - 96,000; Full time

Job summary

Johnson & Johnson in Geel seeks an EMS Expert – Projects to lead and support EMS-related projects, change controls and compliance initiatives within the Geel site’s utilities and clean rooms.

You will act as a content expert for cross-functional projects and advise on quality and compliance impact, partnering with QA, Operations, Engineering & Property Services and QC laboratories to deliver safe, compliant operations.

Qualifications

• Master's diploma in microbiology, biotechnology, (bio)chemistry, pharmaceutical sciences or equivalent by experience.
• Experience leading projects and coordinating improvement initiatives in a GMP environment.
• Thorough knowledge of cGMP regulations and relevant standards (FDA, EU GMP, ISO).
• Knowledge of microbiology and experience in pharmaceutical production and QA/QC/GMP compliance is an asset.
• Excellent collaboration and communication with stakeholders across the organization.

Responsibilities

• Act as EMS expert and central contact for cross-functional projects and site initiatives ensuring continuity and compliant execution.
• Lead and support improvement initiatives related to safety, compliance, quality and operational performance.
• Review and execute change controls and related qualification documentation for equipment/building changes.
• Lead investigations, advise on quality impact and implement corrective/preventive actions.
• Contribute to GMP inspections and audits and ensure timely follow-up of findings.

Skills

Project leadership

GMP compliance

Quality assurance

Cross-functional collab

Documentation

Dutch/English

Education

Master's degree in microbiology, biotechnology, (bio)chemistry, pharma sciences or equivalent by experience

Job description

Johnson & Johnson in Geel seeks an EMS Expert – Projects to lead and support EMS-related projects, change controls and compliance initiatives within the Geel site’s utilities and clean rooms.

You will act as a content expert for cross-functional projects and advise on quality and compliance impact, partnering with QA, Operations, Engineering & Property Services and QC laboratories to deliver safe, compliant operations.