Quality Engineer - Equipment Qualification (GMP/QMS)

Johnson & Johnson Co.; Geel; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Meal vouchers

Additional pension plan

Hospitalization insurance

Job summary

Johnson & Johnson in Geel, Belgium is seeking a Staff Quality Engineer for QA Equipment Qualification within the Innovative Medicine Supply Chain. You will provide quality oversight for production equipment used in SM-API and DP Intermediate manufacturing at the Geel site, contributing to GMP-compliant operations and ongoing improvement.

You will be part of a multidisciplinary team with a strong focus on technology, qualification/validation, automation, and continuous improvement, supporting

Responsibilities

• Assure Equipment Qualification regulatory requirements across the life cycle (concept, project, operation, retirement).
• Review and approve Qualification documents (SOPs, user requirements, risk analyses, Qualification Plans, tests, changes, deviations).
• Maintain knowledge of international laws and guidelines related to Qualification; implement improvements.
• Prepare for and participate in audits and inspections as a spokesperson.
• Perform internal and external audits to ensure regulatory compliance.
• Collaborate with engineering, operations and other teams for new systems and processes.
• Advise on Qualification activities and ensure cGMP compliance in new projects.

Job description

Johnson & Johnson in Geel, Belgium is seeking a Staff Quality Engineer for QA Equipment Qualification within the Innovative Medicine Supply Chain. You will provide quality oversight for production equipment used in SM-API and DP Intermediate manufacturing at the Geel site, contributing to GMP-compliant operations and ongoing improvement.

You will be part of a multidisciplinary team with a strong focus on technology, qualification/validation, automation, and continuous improvement, supporting