Senior 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 Walkersville is hiring a Validation Specialist. This person is responsible for execution of qualifications/re-qualifications of manufacturing facilities, equipment, and processes. Is considered the site SME for one or more areas within validation. Responsible for aligning with the site Validation Master Plans. Will represent validation as a lead for validation projects and resource accordingly to the needs of the project.

This position will report on site daily M-F in our Walkersville MD facility

Key Responsibilities:

  • Supports commissioning activities, projects, and validation functions by performing, preparing, reviewing, and approving validation protocols (IQ, OQ, PQ) 
    and other documentation for facilities, processes, and equipment.  Generates final reports.
  • Drafts, assists in execution, and reviews Environmental Monitoring Process Qualifications (EMPQ) and Aseptic Process Simulation (APS) protocols.  Generates final reports.
  • Responsible for certain day to day activities conducted by the Validation Department and will act as lead for validation projects.
  • Demonstrated ability to forecast and manage project work correctly and independently.
  • Able to be an independent interface to other portions of the organization as assigned, providing updates as requested and seeking out higher level input when necessary.
  • Coordinates activities for projects in which they are the lead. The scope of these projects can be large and complex.
  • Able to coach and mentor junior level specialists.
  • Participates in audits and inspections conducted by internal and external entities, including agencies and clients. Liaise with outside clients as a representative of validation.
  • Demonstrated ability to review policies or procedures for compliance.
  • Oversee the activities of the internal validation staff as well as external validation contractors on projects in which they are the lead. Establishes priorities to ensure that deadlines are met.
  • Perform other duties as assigned.
  • Level of this role (I, II, III, IV/Senior) is dependent upon experience.

Key Requirements:

  • Associates degree or equivalent work experience
  • Intermediate experience with qualification & validation in GMP Environment
  • Familiarity with the use of computers Word, Excel, Outlook, Project, or equivalent
  • Maintain a quality mindset and approach for all projects by ensuring that all team members comply with processes, procedures, and instructions for all activities
  • Provides appropriate coaching and performance feedback to all junior level associates and assures that all team members are being developed
  • Able to handle larger and more complicated project work but with oversight at a moderate degree
  • Capable of independently discussing validation philosophies during customer audits or regulatory inspections in the presence of the manager

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: R42010