Senior CQV Engineer – Biologics GMP Systems

Johnson & Johnson Co.; Leiden; Vor Ort; EUR 54.000 - 85.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Vacation days

Parental leave

Zusammenfassung

Johnson & Johnson Innovative Medicines Biologics in Leiden, Netherlands is recruiting a Senior Qualification Engineer to lead CQV activities for critical biopharma manufacturing systems. You will plan, execute and supervise IQ/OQ/PQ, mentor junior engineers, and ensure regulatory compliance across projects.

The role requires 4+ years in the (bio)pharmaceutical sector, CQV experience, and strong English communication. Located in Leiden with a focus on GMP and continuous improvement.

Qualifikationen

• Bachelor’s degree in Engineering (Chemical, Mechanical, or Industrial) or related field.
• Minimum 4 years of proven experience in the (bio)pharmaceutical industry or related academic experience.
• Minimum 2 years in commissioning, qualification, validation (CQV).
• Familiar with regulations (ICH, EMA, CFR) and ISPE/PDA standards.
• Strong communication skills in English.

Aufgaben

• Lead validation and qualification efforts for critical manufacturing systems and equipment.
• Plan, oversee, and troubleshoot commissioning, qualification, and validation activities.
• Mentor junior qualification engineers and provide training on validated systems.
• Develop qualification plans for complex projects from user requirements and guidelines.
• Execute IQ, OQ, and PQ protocols with cross-functional teams.
• Conduct risk assessments and maintain comprehensive documentation.
• Support change control processes and collaborate with engineering, QA, and production teams.
• Drive continuous improvement of commissioning and qualification processes.

Jobbeschreibung

Johnson & Johnson Innovative Medicines Biologics in Leiden, Netherlands is recruiting a Senior Qualification Engineer to lead CQV activities for critical biopharma manufacturing systems. You will plan, execute and supervise IQ/OQ/PQ, mentor junior engineers, and ensure regulatory compliance across projects.

The role requires 4+ years in the (bio)pharmaceutical sector, CQV experience, and strong English communication. Located in Leiden with a focus on GMP and continuous improvement.