Senior QA Engineer - Manufacturing Equipment Qualification

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Leisure/Health benefits

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson is seeking a Manufacturing Equipment Qualification Engineer within the QA department in Geel, Belgium. You will oversee equipment qualification for SM-API and DP Intermediates, ensuring quality oversight across the production lifecycle and regulatory compliance within GMP frameworks.

You will collaborate with engineering, operations and cross-functional teams, drive audits, validation activities and continuous improvement while upholding cGMP standards and project timelines.

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 Directive 2003/94/EC and annex 11/15; ICH Q7, GAMP, Data Integrity Guidelines…)
• Experience with Equipment Qualification.
• Fluent in verbal and written communication in English and Dutch.

Responsabilités

• Assure that Equipment Qualification related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase).
• Review and approve Qualification documents such as SOPs, user requirements, risks analysis, Qualification Plans, tests, changes, deviations etc. to maintain compliance to regulations and standards.
• Maintain knowledge of international laws, guidelines and evolutions related to Qualification and apply this to improve Equipment Qualification at J&J.
• Prepare for and be spokesperson in audits and inspections.
• Perform and follow up on internal and external audits to accomplish regulatory compliance.
• Cooperate with engineering, operations and other teams for new systems and processes.

Connaissances

English fluency

Dutch fluency

Quality mindset

Analytical thinking

GxP compliance

Audit readiness

Cross-functional collaboration

Project coordination

Formation

Master's degree or equivalent

Description du poste

Johnson & Johnson is seeking a Manufacturing Equipment Qualification Engineer within the QA department in Geel, Belgium. You will oversee equipment qualification for SM-API and DP Intermediates, ensuring quality oversight across the production lifecycle and regulatory compliance within GMP frameworks.

You will collaborate with engineering, operations and cross-functional teams, drive audits, validation activities and continuous improvement while upholding cGMP standards and project timelines.