Senior C&Q Engineer – Atlas Equipment Expansion

Johnson & Johnson Innovative Medicine; Geel; On-site; EUR 73,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in Geel/Beerse, Belgium, seeks a Senior C&Q Engineer as part of Global Engineering and Technology to lead end-to-end qualification of Atlas process equipment for a major capacity expansion.

You will collaborate with Process Eng, Automation, Safety, Maintenance, QA, and Operations; applying risk-based qualification, ensuring regulatory compliance, and acting as SME for the KNEAT tool during inspections and audits.

Qualifications

• Deep understanding of FDA and EMA equipment qualification requirements and industry standards (ICH Q7, ISPE C&Q, GAMP 5, ASTM E2500).
• Hands-on experience leading commissioning and qualification activities preferred.
• Strong communication and collaboration across multiple functions.
• Proficient in Dutch (or willingness to learn) and English.

Responsibilities

• End-to-end ownership of Atlas equipment qualification strategy.
• Define and review qualification deliverables (PVP, URS, Risk & Impact, DQ/IQ/OQ/PQ, Quality Summary).
• Coordinate qualification activities by A/E partner for design/engineering execution.
• Guide teams in risk-based qualification aligning with standards and regulatory expectations.
• Partner with Process Eng, Automation, Technical Safety, Maintenance, QA.

Skills

FDA/EMA standards

C&Q leadership

Validation protocols

Risk-based qualification

Dutch & English

Education

Master's degree or equivalent in Engineering/Science

Job description

Johnson & Johnson in Geel/Beerse, Belgium, seeks a Senior C&Q Engineer as part of Global Engineering and Technology to lead end-to-end qualification of Atlas process equipment for a major capacity expansion.

You will collaborate with Process Eng, Automation, Safety, Maintenance, QA, and Operations; applying risk-based qualification, ensuring regulatory compliance, and acting as SME for the KNEAT tool during inspections and audits.