QA - Manufacturing Equipment Qualification Engineer (Pharmaceutical Manufacturing)

Location: Geel, Antwerp, Belgium

Salary: €60,000–€96,255 per year

Company

Johnson & Johnson MedTech develops healthcare and pharmaceutical solutions, with the Geel site focused on manufacturing small-molecule active pharmaceutical ingredients and drug product intermediates.

What you will do

• Provide quality oversight for production equipment throughout the concept, project, operational, and retirement lifecycle.
• Review and approve SOPs, user requirements, risk analyses, qualification plans, tests, changes, deviations, and other qualification records.
• Maintain and improve equipment qualification practices in line with international regulations, guidelines, and company standards.
• Prepare for and act as a spokesperson during audits and inspections, while following up on internal and external audits.
• Support engineering, operations, and cross-functional teams in introducing new systems and processes within the cGMP framework.
• Ensure compliant handling of change controls, investigations, CAPAs, and other quality records for innovation projects.

Requirements

• Master’s degree in a scientific field or equivalent experience.
• 4–6 years of experience in the pharmaceutical or chemical industry.
• Knowledge of cGMP and qualification requirements, including 21 CFR Part 211, EU requirements, ICH Q7, GAMP, and data integrity guidelines.
• Experience with equipment qualification, risk-based decision-making, analytical thinking, and quality systems documentation.
• Fluent written and spoken English and Dutch are required.
• Ability to work accurately, proactively, and flexibly across organizational boundaries and under time pressure.

Nice to have

• Experience with automated manufacturing practices, process improvement, quality validation, and lean supply chain management.
• Understanding of AI concepts and frameworks, responsible AI practices, and prompt generation.

Culture & Benefits

• Indefinite-duration employment contract with an attractive salary package.
• Meal vouchers, additional pension plan, hospitalization insurance, and other benefits.
• Annual bonus, vacation days, parental leave, caregiver leave, bereavement leave, and volunteer leave.
• Professional development through on-the-job training, e-learning, projects, and educational opportunities.
• Dynamic working environment with challenging projects and a strong focus on continuous improvement.