Validation Specialist

Walkersville, Maryland

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 Specialist will be responsible for the writing and execution of project and system qualification validations, re-qualifications and re-validation of manufacturing facilities, equipment, utilities and processes. The candidate must have a strong emphasis in qualifying autoclaves, sterilization ovens, and lyophilizers. Possess a strong understanding of log reduction in the sterilization process with both EU and ISO standards. 

Key responsibilities:

  • Demonstrated ability to forecast and manage project work correctly and independently.
  • Ability to mentor junior level specialists.
  • Represent Validation and Quality during customer audits or regulatory inspections.
  • Demonstrated ability to review policies and procedures for compliance with regulatory guidance.
  • Able to correctly assess all change controls.
  • Able to resolve discrepancies on the basis of risks involved.
  • Able to clearly and concisely write protocols, deviations and final reports.
  • Demonstrated technical writing skills and thorough understanding of root cause analysis. 
  • Participate in investigations and process (CIP (Clean in Place), SIP (Steam in Place), Autoclave) failure investigations and CAPAs.
  • Assess impact of process / equipment or procedural changes that can affect the validated state of the equipment.
  • Review URS’s (User Requirement Specifications) and provide guidance and recommendations on an engineering project.
  • Working in safe manner is an expectation and safety training must be up to date.
  • Ability to work in a cross functional group as needed to resolve general equipment or manufacturing deficiencies.
  • Specialists may be required to work off-shift or weekends to support manufacturing operations (less than 10% of the time).
  • Support of Operational Excellence activities for the Site.

Key requirements:

  • Bachelor’s degree in a technical discipline (preferred)
  • Substantial experience in a cGMP environment (working with autoclaves, lyophilizers, sterilization ovens and other equipment supporting GMP production activities.)
  • Substantial Equipment Validation experience
  • Familiarity with the use of computers Word, Excel, Outlook, Project or equivalents.
  • Ability to read and follow technical instructions in English.
  • Ability to comply with detailed procedures.
  • Contact with internal customers.
  • Some of this work requires entry into a laboratory or cleanroom setting.

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: R20650