Validation Engineer

United States, Hayward (California)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

The Validation Engineer would be responsible for generating and implementing protocols for the installation, operational and performance qualification of Equipment, CSV, Utilities, Sterilization, Materials Qualification, Processes and Cleaning in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry practices. Serve as a subject matter expert, and track and report action plan status/ completion as relates to validation systems improvement efforts.

Key responsibilities:

  • Documents User Requirements, Design Specification, Configuration Specification, Requirements Traceability Matrix.
  • Produces Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs as required to meet 21 CFR Part 11 requirements, GAMP, among others.
  • Performs periodic reviews, requalification’s and ongoing support of validated systems post Go-Live. Responsible for protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports.
  • Works with Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
  • Supports regulatory and client audits as a subject matter expert.
  • Provide cGMP documents including, but not limited to, SOPs, batch records, validation protocols and reports.

Key requirements:

  • Bachelor’s degree in Engineering or related field.
  • Advanced experience in pharmaceutical, biotechnology, or related industry.
  • Fundamental understanding of validated computer systems, equipment, sterilization, utilities, process, cleaning and change management in the pharmaceutical/biotech industry, including training others.
  • GMP compliance knowledge including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement 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: R29707