Senior Validation Engineer – Biopharma, Relocation & Visa

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

Benefits offered by this job

Agile career culture

Inclusive workplace

Performance-based compensation

Global benefits on Lonza careers site

Job summary

Lonza Geleen is seeking a Senior Validation Engineer to lead qualification and validation activities for equipment, facilities, utilities, and computerized systems in a biopharma production facility. You will ensure compliance with global regulations, industry standards, and Lonza quality systems.

You will mentor junior engineers, perform risk assessments, and drive CAPA-based improvements across the manufacturing lifecycle, collaborating with IT, QA, and operations teams to enable robust,

Qualifications

• Bachelor’s or Master’s degree in Engineering (Chemical, Biomedical, Mechanical, or related field) or a related scientific discipline.
• Minimum of 7 years of progressive validation experience in pharmaceutical/biopharmaceutical industry.
• Demonstrated expertise in validation principles, regulations (GxP, FDA 21 CFR Part 11), and industry standards.

Responsibilities

• Develop, execute, and review validation plans, protocols (IQ, OQ, PQ, CSV) and reports for equipment, facilities, utilities, and computer systems.
• Act as subject matter expert, mentoring junior engineers and cross-functional teams.
• Perform risk assessments (e.g., FMEA) to identify gaps and mitigation strategies.
• Collaborate with Manufacturing, Quality Control, QA, Engineering, and IT to integrate validation efforts across the product lifecycle.
• Investigate deviations, non-conformances, and CAPAs with effective corrective actions.
• Participate in internal and external audits representing the validation department.
• Stay current with regulatory requirements (FDA, EMA, ICH) and industry best practices in validation.
• Support development of training on validation principles and procedures.
• Support continuous improvement of validation processes and documentation.

Skills

Validation principles

IQ/OQ/PQ/CSV

GxP & 21 CFR Part 11

Biopharma manufacturing

Cross-functional collaboration

Education

Bachelor’s or Master’s in Engineering or related field

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 qualification and validation activities for equipment, facilities, utilities, and computerized systems in a biopharma production facility. You will ensure compliance with global regulations, industry standards, and Lonza quality systems.

You will mentor junior engineers, perform risk assessments, and drive CAPA-based improvements across the manufacturing lifecycle, collaborating with IT, QA, and operations teams to enable robust,