CSV Engineer

United States, Houston (Texas)

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.

Lonza Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity in the Quality Assurance Validations group. The Computer Systems Validation engineering position will be serving as a subject matter expert, track and report action plan status/ completion as it relates to validation systems improvement efforts as well as manage the development and the execution of qualifications, validations, re-qualifications and re-validations for process equipment, utilities and facilities, focusing on the computer validation aspects of the systems.

Key responsibilities:

  • Develops CSV Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
  • Supports regulatory and client audits as CSV subject matter expert.
  • Generates and executes (as applicable) User Requirements, Design Specification, Functional Specification and Traceability Matrix. Produces Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs as required to meet 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5 and ISO 13485:2003 requirements among others.
  • Advanced knowledge of discipline; able to discuss regulatory expectations for validation activities, program and documentation.
  • Demonstrated ability to plan and organize validation activities among cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
  • Capable of independently discussing computer systems validation philosophies during customer audits or regulatory inspections in the presence of senior management. Capable of correctly answering questions about day-to-day activities that would be most likely posed by more junior Validation Engineering personnel. Supports implementation of site-wide/departmental projects and initiatives. 
  • Develops, monitors, and reports metrics for computer systems validation activities for individual projects
  • Participates in the initial assessment of change controls for process, laboratory, classified facilities and clean process utilities.  Assessment primary focus being in the CSV portion of the system/equipment.

Key requirements:

  • Bachelor’s degree in life sciences or Engineering required.
  • GMP experience in the biologics and pharma industry. Working knowledge of equipment/facilities qualifications, GMP and GDP environment
  • Highly Experienced in Computer Systems Validation
  • Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities
  • Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others.
  • GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements, among others
  • Capable of leading teams and identifying appropriate path to meet team objectives.

     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: R21767