Quality Engineer – Equipment Qualification (SM‑API)

Johnson & Johnson Co.; Geel; On-site; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Meal vouchers

Pension plan

Hospitalization insurance

Annual bonus

Job summary

Johnson & Johnson in Geel, Belgium seeks a Quality Engineer – QA Equipment Qualification to oversee equipment qualification across the life cycle in a fast-paced Innovative Medicine Supply Chain environment.

You will review qualification documents, stay current with global regulations, prepare for audits and work with engineering, operations and other teams to implement compliant systems. This role offers a permanent contract and attractive benefits.

Qualifications

• Master scientific degree or equivalent experience.
• 4-6 years’ experience in pharmaceutical or chemical industry.
• Knowledge of cGMP/Qualification compliance (21 CFR Parts 211; EU directives; ICH Q7; GAMP).
• Fluent in English and Dutch.
• Strong ownership and quality attitude.
• Ability to deliver on commitment timelines.
• Strong analytical thinking under time pressure.
• Ability to make risk-based decisions.
• Understanding of business implications of quality positions.
• Team player across organizational boundaries.
• Awareness of AI concepts and prompts for process improvement.

Responsibilities

• Assure Equipment Qualification regulatory requirements across the complete life cycle.
• Review and approve Qualification documents (SOPs, user requirements, risks analyses, Qualification Plans, tests, changes, deviations).
• Maintain knowledge of international laws, guidelines and evolutions related to Qualification.
• Prepare for and be spokesperson in audits and inspections.
• Perform internal and external audits to ensure regulatory compliance.
• Cooperate with engineering, operations and other teams for new systems and processes.
• Advise on Qualification activities and GMP considerations in projects.
• Be part of multi-functional teams to realize cross-departmental objectives.
• Ensure that Innovation projects follow GMP Quality framework.

Skills

Quality Engineering

cGMP compliance

Equipment Qualification

Audits

English Dutch fluency

Education

Master degree or equivalent

Job description

Johnson & Johnson in Geel, Belgium seeks a Quality Engineer – QA Equipment Qualification to oversee equipment qualification across the life cycle in a fast-paced Innovative Medicine Supply Chain environment.

You will review qualification documents, stay current with global regulations, prepare for audits and work with engineering, operations and other teams to implement compliant systems. This role offers a permanent contract and attractive benefits.