Validation Engineer II
About the Role
We are looking for a Validation Engineer II to join our team and support qualification and validation activities across equipment, utilities, facilities, and temperature-controlled systems. In this role, you will work closely with Manufacturing, Quality, Engineering, and other cross-functional teams to ensure systems operate in compliance with regulatory requirements and quality standards. This is an excellent opportunity for an experienced validation professional to contribute to the delivery of life-changing therapies in a regulated biopharmaceutical environment.
Workplace Policy: This is an on-site position working Monday through Friday on first shift.
What You'll Get
Opportunity to work on advanced biopharmaceutical manufacturing systems that directly support the production of innovative therapies.
Exposure to cross-functional projects involving Engineering, Manufacturing, Quality, and Validation teams.
Professional development opportunities within a global leader in life sciences.
Collaborative and inclusive environment focused on continuous improvement and operational excellence.
Competitive compensation and a valuable opportunity to expand your validation and compliance expertise.
MSP Fixed Copy
Key Responsibilities
Develop, execute, and maintain qualification and validation protocols and reports for equipment, utilities, and facilities, including Installation Qualification, Operational Qualification, and Performance Qualification activities.
Perform commissioning, qualification, and validation activities for temperature-controlled units, including temperature mapping studies.
Coordinate validation projects with Manufacturing, Quality Assurance, Engineering, and Research and Development teams to ensure timely execution and compliance.
Analyze validation data, investigate deviations, and recommend corrective and preventive actions to support continuous improvement.
Prepare validation documentation, technical reports, and summary packages for internal review and regulatory inspections.
Support change control activities by assessing the impact of proposed changes on validated systems and processes.
Contribute to audit readiness by ensuring validation records are accurate, complete, and compliant with regulatory requirements.
Key Requirements
Bachelor's degree in Engineering, Life Sciences, or a related scientific discipline.
2 to 6 years of validation experience within the pharmaceutical, biotechnology, or biopharmaceutical industry.
Experience developing and executing Installation Qualification, Operational Qualification, and Performance Qualification protocols.
Hands-on experience with temperature mapping of controlled temperature units and related qualification activities.
Strong knowledge of Good Manufacturing Practice requirements, regulatory expectations, and industry guidelines.
Strong analytical, problem-solving, and technical writing skills with attention to detail.
Effective communication and collaboration skills with the ability to work across multiple functions and manage competing priorities.
About Lonza
Founded in 1897 in the Swiss Alps, our business has embraced innovation and kept pace with a fast-changing world for more than 125 years.
We are the CDMO that opened the door to a new era of medicine – one where breakthroughs could be produced at scale and made available around the world. Our contributions have led the way in drug approvals in our industry.
The therapies we help bring to life reach up to 100 million people each year, and we contribute to around one in every ten medicines that are newly approved by the FDA.
Political, regulatory, or economic disruption in one region doesn’t put the brakes on our business as our global network of 30+ sites across five continents provides resilience against global instability.
We are a community of big thinkers and bold doers. We focus on what matters, and together we make it happen. We are constantly pushing ourselves to make things better, never stopping until we make it right.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, protected veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.
At Lonza, we are committed to building an inclusive workplace where diverse perspectives are valued and respected. We believe that diversity strengthens our teams, drives innovation, and helps us better serve our employees, customers, and communities. Reasonable accommodations are available for qualified individuals with disabilities throughout the recruitment process.
