Senior CQV Engineer - Biopharma Validation Leader

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; On-site; EUR 53,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days and parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicines Biologics Biologics in Leiden, Netherlands, is recruiting a Sr. Qualification Engineer to support commissioning and qualification of complex systems for biotherapeutics manufacturing.

The role requires a strong CQV background, knowledge of ICH/EMA/CFR, and collaboration with cross-functional teams to ensure compliant validation activities. Leiden site offers growth within a high-performance culture focused on safety, quality, and innovation.

Qualifications

• Bachelor’s degree or equivalent degree in Engineering (Chemical, Mechanical, or Industrial) or other scientific field is required.
• Minimum 4 years of proven experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• 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).

Responsibilities

• 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, identifying and mitigating potential risks.
• Generate and maintain comprehensive documentation, including test scripts, reports, and validation protocols, ensuring regulatory compliance.
• Participate in change control processes, assessing impact of changes on validated systems.
• Collaborate with engineering, quality assurance, and production teams to ensure detailed integration of new systems.
• Identify and resolve issues related to equipment, systems, or processes during commissioning and qualification phases.
• Foster skill development within the team by coaching junior qualification engineers
• Provide training to relevant personnel on validated systems and associated processes.
• Contribute to continuous improvement initiatives by recommending enhancements to commissioning and qualification processes.

Skills

Communication skills

English proficiency

Education

Bachelor’s degree in Engineering

Job description

Johnson & Johnson Innovative Medicines Biologics Biologics in Leiden, Netherlands, is recruiting a Sr. Qualification Engineer to support commissioning and qualification of complex systems for biotherapeutics manufacturing.

The role requires a strong CQV background, knowledge of ICH/EMA/CFR, and collaboration with cross-functional teams to ensure compliant validation activities. Leiden site offers growth within a high-performance culture focused on safety, quality, and innovation.