Engineer (Validation)

Job description

Singapore, Tuas Singapore

Today, Lonza is a global leader in life sciences operating across three 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.

Lonza Singapore belongs to the Biologics business unit and plays a critical role in supporting GMP manufacturing operations for biopharmaceutical products.

The Engineering team ensures smooth, reliable, and compliant operation of equipment and facilities to support the production of life-saving medicines.

As a
Validation
Engineer
, you will support the validation of computerized systems in a Good Manufacturing Practice (GMP) pharmaceutical environment, ensuring compliance with regulatory requirements and industry best practices.

You will work closely with cross-functional teams, including Engineering, Quality, Automation, and IT, to validate systems that support manufacturing, laboratory, and business processes.

Our ambitious vision is to successfully implement innovative solutions that make a positive difference.

If you have the determination to inspire change, this is the role for you.

What You Will Get

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• Daily company bus from the MRT location near your home to and from the Tuas site
• Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums
• Opportunities to drive continuous improvement in a high-impact environment

What You Will Do

• Supports computerized system validation (CSV) activities for GMP-regulated systems, including manufacturing, laboratory, and business applications.
  
  
• Perform day-to-day Validation activities in accordance with approved Validation SOPs / Plan / Policies
• Develop & execute Validation Protocols and Reports, including supporting site discrepancies and deviations investigation / closure
• Collaborate with vendors and other Engineering functions to perform technical evaluation of the new equipment or modification, so as to develop appropriate protocol that will demonstrate that the equipment or modification meet the user or project requirements
• Participate in system design review to ensure compliance to user requirements, good engineering practice, validation requirements and regulatory standards
• Collaborate with other Engineering functions, End-User and Quality team to ensure the Validation activities are completed as planned
• Review Engineering documents associated with commissioning and validation activities
• Participate in Site Validation Maintenance Program
• Participate in commissioning activities when required
• Support Change Implementation on site
• Support for customer and regulatory audit / inspections as required

What We Are Looking For

• Degree in Engineering (Mechanical, Chemical, Biomedical, etc).
  
  
• Strong experience in computerized system validation (CSV) or automation in GMP regulated industry.
  
  
• Good understanding of regulations and industry standards relating to computerized system including data integrity principles.
  
  
• Ability to read and interpret technical documentation, system specifications, and validation protocols.
  
  
• Strong analytical, problem-solving, and organizational skills.
  
  
• Excellent communication skills and ability to work in a team-oriented environment.
  
  
• Willingness to learn and adapt in a fast-paced, regulated industry.
  
  

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 — the satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R70804

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