Quality Engineering Manager – Facilities & Equipment

Biopharma Careers; Geel; Sur place; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Healthcare coverage

Résumé du poste

Johnson & Johnson in Geel, Belgium, is recruiting a Manager Quality Engineering – Facilities Utilities Equipment within a QA department. You will lead QA qualification activities for facilities, utilities, and production equipment used for APIs and DP Intermediates at the Geel site.

You will manage a QA qualification team, oversee resources and budget, and ensure compliance with cGMP and regulatory requirements, while driving continuous improvements and professional development opportunities.

Qualifications

• Master scientific degree or equivalent experience.
• 5-10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.
• Thorough knowledge of cGMP regulations and guidelines in the area of qualification.
• Knowledge of the different systems used during the manufacturing process.
• Strong analytical thinking, risk assessment, communication, managerial and leadership skills.
• Collaboration and teaming skills.
• Mindset for innovation and optimization.
• Fluent in Dutch and English (written and spoken).

Responsabilités

• QA Qualification Operational activities: maintaining qualification status during system life cycle.
• Review and approve qualification documents, PQPs and calibration records.
• Participate in system introduction and system change projects with quality and compliance focus.
• Prepare for regulatory inspections and act as QA qualification spokesperson.
• Evaluate deviations related to systems and implement CAPAs.
• Continuously improve qualification processes and pursue best practices.
• Maintain current knowledge of international regulations and industry practices.

Connaissances

GMP

ISO 9001

QMS

SOP

Regulatory

Quality Validation

Quality Management

Process Improvements

Continuous Improvement

Formation

Master scientific degree

Description du poste

Johnson & Johnson in Geel, Belgium, is recruiting a Manager Quality Engineering – Facilities Utilities Equipment within a QA department. You will lead QA qualification activities for facilities, utilities, and production equipment used for APIs and DP Intermediates at the Geel site.

You will manage a QA qualification team, oversee resources and budget, and ensure compliance with cGMP and regulatory requirements, while driving continuous improvements and professional development opportunities.