Validation Specialist

United States, Walkersville (Maryland)

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 is adding a Validation Specialist to support Computer Systems Validation (CSV) and Data Integrity (DI) initiatives at our site in Walkersville, Maryland.  The role represents the Validation Team as a lead for projects and reports to the Associate Director.  Duties include writing and the execution of qualifications/re-qualifications of manufacturing facilities, computer systems, equipment, and processes.   The best candidate would be the site Subject Matter Expert (SME) for one or more areas within Validation.   The QA Floor Specialist is responsible for aligning with the site Validation Master Plans and supporting general validation activities.  Occasional travel to Salisbury, Maryland site.

Key responsibilities:

  • Oversee/Plan/Perform CSV qualification activities with internal, external, local, and global guidelines and regulations;
  • Support commissioning activities, projects, and validation functions by performing, preparing and reviewing/approving validation protocols and other documentation for equipment, facilities, and processes.
  • Execute responsibilities as CSV lead for validation related projects; Generate validation final reports.
  • Perform Validation Maintenance and periodic reviews of computerized systems.
  • Monitors the performance of validation projects by tracking appropriate metrics and reporting the results to management.
  • Review and revise CSV SOPs
  • Coach and mentor junior level specialists
  • Participate in audits and inspections conducted by internal and external entities, agencies and clients.
  • Adhere to cGMP and own quality of work and deliverables in a timely manner
  • Handle tasks, deviations, CAPAs, observations, and change controls assigned in Trackwise.  Manage to completion in addition to review and oversight.
  • Follow job safety policies and procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. 

Key requirements:

  • Associate’s Degree in Science or Engineering required; Bachelor’s Degree, preferred; equivalent work experience will be considered
  • Significant knowledge of Computer Systems Validation (CSV) and experience from a Pharmaceutical or Chemical Manufacturing or Medical device environment
  • Working knowledge of Microsoft Office required
  • Must be able to walk, sit and stand for several hours; kneel, squat, bend, climb stairs and ladders as needed;  Must be able to lift up to 50lbs.
  • Knowledge of ISPE GAMP guidelines
  • Significant knowledge and experience in:
    • 21 CFR Part 11 guidelines
    • Validation IQ, OQ, and PQ protocols
    • Temperature Mapping experience
    • Time Management, Project Management and Schedules
  • SAP and Trackwise experience, preferred
  • Capable of independently discussing validation philosophies during customer audits or regulatory inspections in the presence of a Supervisor.
  • Must be willing to work after regular Monday - Friday business hours including weekends when required. 

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: R42697