Senior Validation Engineer

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

Senior Validation Engineer

Location: Geleen (Relocation & visa support available)

We are seeking a highly skilled and experienced Senior Validation Engineer to lead and execute qualification and validation activities for equipment, facility, utilities and (computerized) systems within our biopharmaceutical production facility. This role ensures compliance with national and international regulations, industry standards, and internal quality management systems, contributing to the consistent delivery of high-quality products.

What You Will Get

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• A variety of benefits dependent on role and location
• The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.

The full-time annual base pay for this position in The Netherlands is expected to range between 57.000,- EUR and 79.800,- EUR. Initial salary placement within this range will be determined based on role‑related factors such as experience, qualifications, and expected contribution.

What You Will Do

• Develop, execute, and review validation plans, protocols (IQ, OQ, PQ, CSV), and reports for a wide range of equipment, facilities, utilities, and computer systems.
• Act as a subject matter expert for validation activities, providing technical guidance and mentorship to junior engineers and cross-functional teams.
• Perform risk assessments (e.g., FMEA) to identify potential validation gaps and develop mitigation strategies.
• Collaborate closely with Manufacturing, Quality Control, Quality Assurance, Engineering, and IT departments to ensure seamless integration of validation efforts throughout the product lifecycle.
• Investigate and resolve validation deviations, out-of-specification results, and non-conformances, implementing effective corrective and preventive actions (CAPAs).
• Participate in internal and external audits, representing the validation department and providing documentation and expertise.
• Stay abreast of current industry trends, regulatory requirements (e.g., FDA, EMA, ICH), and best practices in validation.
• Support development of training on validation principles and procedures to relevant personnel.
• Support the continuous improvement of validation processes and documentation.

What We Are Looking For

• Bachelor's or Master's degree in Engineering (Chemical, Biomedical, Mechanical, or related field), Biotechnology, or a related scientific discipline.
• Minimum of 7 years of progressive experience in validation within the pharmaceutical or biopharmaceutical industry.
• Demonstrated expertise in validation principles, regulations (e.g., GxP, FDA 21 CFR Part 11), and industry standards.
• Proven experience in developing and executing IQ, OQ, PQ, and CSV protocols and reports.
• Strong understanding of biopharmaceutical manufacturing processes and associated equipment.
• Experience in GMP environment.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficient in technical writing and documentation.
• Strong interpersonal and communication skills, with the ability to effectively collaborate with diverse teams.
• Ability to manage multiple projects concurrently and meet challenging deadlines.

Strong Plus

• Experience with quality assurance
• Experience with quality management, computerized maintenance, and validation systems (e.g., Kneat Gx, ValGenesis, TrackWise, Veeva QualityDocs, SAP PM, IBM Maximo, LIMS, MES, and other GxP-regulated computerized systems) is a plus.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R78782