Qualification and Validation Specialist

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As a Qualification and Validation Specialist at Lonza, you will be responsible for ensuring that manufacturing facilities, equipment, utilities, and systems are qualified and validated in compliance with regulatory and quality requirements. You will work closely with Engineering, Quality, Manufacturing, and Project teams to support compliant operations, regulatory readiness, and successful project delivery.

Join Lonza to gain exposure to GMP manufacturing environments, regulatory inspections, and complex validation programs, while contributing directly to the delivery of safe, high-quality products that improve lives globally.

What you’ll get

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

• Opportunities to work on greenfield and brownfield projects in a regulated GMP environment.

• Exposure to global quality standards and regulatory frameworks.

The full list of our global benefits can be found at:
https://www.lonza.com/careers/benefits

What you’ll do

• Plan and execute qualification and validation activities (DQ, IQ, OQ, PQ) for manufacturing equipment, utilities (HVAC, water systems, compressed air, steam), facilities, cleanrooms, and laboratory instruments.

• Ensure validation activities are aligned with project timelines, regulatory expectations, and Lonza quality standards.

• Prepare, review, and support approval of qualification and validation protocols, reports, and summary documentation.

• Ensure all validation activities comply with Indian GMP (Schedule M), CDSCO requirements, WHO-GMP guidelines, and applicable global regulatory standards.

• Support regulatory inspections, audits, and certifications through preparation of documentation, participation in audits, and timely response to observations and queries.

• Develop and maintain validation lifecycle documentation, including Validation Master Plans (VMPs), risk assessments (FMEA, QRM), change control and deviation impact assessments, and periodic review and requalification activities.

• Support process validation activities (PPQ / CPV) and cleaning validation for manufacturing equipment and facilities.

• Coordinate and support Computer System Validation (CSV) activities for manufacturing, laboratory, automation, BMS/EMS, ERP, LIMS, and quality systems, as applicable.

• Work cross-functionally with Engineering, Production, QA, QC, IT, and Project teams, providing validation input during design, FAT/SAT, commissioning, handover, and technology transfer activities.

• Contribute to continuous improvement initiatives by applying risk-based validation approaches and supporting the development of SOPs, templates, and best practices.

• Support training of cross-functional teams on validation principles, regulatory expectations, and compliance requirements.

What we’re looking for

• Bachelor’s degree in Pharmacy, or a related scientific discipline.

• Post-graduate qualification in Quality Assurance, Pharmaceutical Sciences, or a related field is preferred.

• 8–12 years of experience in qualification and validation within a regulated pharmaceutical or life sciences environment.

• Strong exposure to GMP-compliant facilities, equipment, and utility qualification.

• Hands-on experience supporting CDSCO and WHO-GMP audits and inspections.

• Experience in greenfield and/or brownfield projects is highly desirable.

• In-depth knowledge of GMP, CDSCO, WHO-GMP, and regulatory validation requirements.

• Strong understanding of risk-based validation and lifecycle management principles.

• Excellent documentation, analytical, and problem-solving skills with high attention to detail and data integrity.

• Ability to manage multiple stakeholders and deliver results in a project-driven environment.

• High standards of integrity, compliance mindset, and strong communication skills.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world — and making a meaningful difference.