Senior CQV Engineer - GMP Validation Leader

Johnson Johnson; Leiden; Vor Ort; EUR 54.000 - 85.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicines Biologics Leiden is recruiting a Senior Qualification Engineer to lead validation and qualification for critical manufacturing systems and equipment. You will plan, oversee, and troubleshoot commissioning, qualification, and validation activities while mentoring junior staff.

The role emphasizes regulatory alignment with ICH/EMA/CFR, cGMP inspections, and continuous improvement within a high-performance manufacturing site in Leiden.

Qualifikationen

• Minimum 4 years of proven experience in the (bio)pharmaceutical industry or related academic experience.
• Minimum 2 years of proven experience working in a commissioning, qualification, validation (CQV) role.
• Familiar with regulations (ICH, EMA, CFR) and industry standard (ISPE, PDA).
• Accurate, structured, flexible and customer focused.
• Good communication skills in English (both oral and written).

Aufgaben

• Support the commissioning process for new or upgraded systems, ensuring proper installation and functionality.
• Develop qualification plans for highly complex projects based on user requirements, regulatory guidelines, and company standards.
• Execute IQ, OQ, and PQ protocols in collaboration with cross-functional teams.
• Conduct risk assessments related to commissioning and qualification activities.
• Generate and maintain documentation including test scripts, reports, and validation protocols.
• Collaborate with engineering, quality assurance, and production teams to ensure integration of new systems and modifications.
• Coach junior qualification engineers and provide training on validated systems.

Kenntnisse

English

CQV experience

Project management

Regulatory knowledge

Quality Assurance

Ausbildung

Bachelor's degree in Engineering

Jobbeschreibung

Johnson & Johnson Innovative Medicines Biologics Leiden is recruiting a Senior Qualification Engineer to lead validation and qualification for critical manufacturing systems and equipment. You will plan, oversee, and troubleshoot commissioning, qualification, and validation activities while mentoring junior staff.

The role emphasizes regulatory alignment with ICH/EMA/CFR, cGMP inspections, and continuous improvement within a high-performance manufacturing site in Leiden.