Senior Validation Engineer: Lead IQ/OQ/PQ & CSV

Lonza; Geleen; On-site; Confidential; Full time

Benefits offered by this job

Agile career culture

Inclusive workplace

Performance-based compensation

Benefits package

Job summary

Lonza Geleen is seeking a Senior Validation Engineer to lead validation activities for equipment, facilities, utilities, and computerized systems at our Dutch site. You will ensure compliance with GxP and FDA/EMA guidelines, while mentoring junior engineers and coordinating with cross-functional teams.

Success requires 7+ years in pharma/biopharma validation, strong writing and analytical skills, and a deep understanding of validation lifecycle processes.

Qualifications

• Bachelor’s or Master’s degree in Engineering or related scientific field.
• Minimum of 7 years of progressive validation experience in pharma/biopharma.
• Proven expertise in validation principles, regulations (GxP, FDA), and industry standards.
• Experience developing IQ/OQ/PQ/CSV protocols and reports.
• Strong understanding of biopharma manufacturing processes and GMP environment.

Responsibilities

• Develop, execute, and review validation plans, protocols, and reports for equipment, facilities, utilities, and computer systems.
• Act as SME for validation activities and mentor junior engineers.
• Perform risk assessments and implement CAPAs.
• Collaborate with Manufacturing, Quality, Engineering, and IT to integrate validation across the lifecycle.
• Lead audits and stay updated on regulatory requirements.

Skills

Validation planning

GxP compliance

Technical writing

Cross-functional collaboration

Project management

Analytical thinking

Education

Bachelor’s or Master’s degree in Engineering (Chemical, Biomedical, Mechanical)

Tools

Kneat Gx

ValGenesis

TrackWise

Veeva QualityDocs

SAP PM

IBM Maximo

LIMS/MES

Job description

Lonza Geleen is seeking a Senior Validation Engineer to lead validation activities for equipment, facilities, utilities, and computerized systems at our Dutch site. You will ensure compliance with GxP and FDA/EMA guidelines, while mentoring junior engineers and coordinating with cross-functional teams.

Success requires 7+ years in pharma/biopharma validation, strong writing and analytical skills, and a deep understanding of validation lifecycle processes.