Senior CQV Engineer - Biopharma GMP Validation

Johnson & Johnson Innovative Medicine; Leiden; Sur place; EUR 54 000 - 85 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicines Biologics Biologics in Leiden, Netherlands, seeks a Senior Qualification Engineer to lead validation and qualification efforts for critical manufacturing systems, ensuring alignment with regulatory standards. You will plan, oversee, and troubleshoot commissioning, qualification, and validation activities and mentor junior teammates.

The role requires 4+ years in the (bio)pharmaceutical industry, 2+ years in CQV, knowledge of ICH/EMA/CFR, and strong

Qualifications

• Minimum 4 years in (bio)pharmaceutical industry or related academic experience.
• Minimum 2 years in commissioning, qualification, validation (CQV).
• Familiar with regulations (ICH, EMA, CFR) and industry standards (ISPE, PDA).

Responsabilités

• Support the commissioning of new or upgraded systems.
• Develop qualification plans for complex projects.
• Execute IQ, OQ, and PQ protocols with cross-functional teams.
• Conduct risk assessments for commissioning activities.
• Generate and maintain validation documentation.
• Participate in change control processes.
• Collaborate with engineering, QA, and production teams.
• Coach junior qualification engineers and provide training.

Connaissances

CQV experience

IQ/OQ/PQ

English proficiency

GMP/Regulatory knowledge

Project management

Formation

Bachelor’s degree in Engineering

Description du poste

Johnson & Johnson Innovative Medicines Biologics Biologics in Leiden, Netherlands, seeks a Senior Qualification Engineer to lead validation and qualification efforts for critical manufacturing systems, ensuring alignment with regulatory standards. You will plan, oversee, and troubleshoot commissioning, qualification, and validation activities and mentor junior teammates.

The role requires 4+ years in the (bio)pharmaceutical industry, 2+ years in CQV, knowledge of ICH/EMA/CFR, and strong