Process Validation Scientist

United States, Portsmouth (New Hampshire)

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 in Portsmouth, NH is looking for an experience Process Validation (PV) Scientist for our Manufacturing Science and Technology (MSAT) team.  As part of the dynamic MSAT team, our Process Validation Scientist holds the responsibility to support the validation of our processes by providing project support during technology transfers, executing validation studies, and collaborating with various departments.

Key responsibilities:

  • Supervise a small team of Process Validation (PV) Scientists and prioritize workloads to successfully deliver PV projects.
  • Coordinate PV technical transfer activities with customers and internal stakeholders.
  • Oversee protocol development, protocol execution, and final reporting of PV document packages.
  • Coach and develop direct reports.
  • Identify and implement continuous improvement projects.
  • Comprehension of PV technical activities with minimal assistance and supervision. Examples of PV activities include, but are not limited to, generating Process Validation Plans, Process Performance Qualification Protocols, Large-Scale Resin and Membrane Lifetime Protocols, Media Pre-filtration and Mixing Protocols, Microbial Hold Protocols, and Reprocessing Protocols.
  • Ability to deduce information provided by various departments to conclude product impact, process validation impact, and corrective actions. 

Key requirements:

  • Bachelor of Science degree in Biological Sciences, or Biomedical/Chemical Engineering.
  • Significant experience in biotech industry and validations.
  • Significant knowledge with large/small scale mammalian or cellular therapies manufacturing support, cGMP and US/EU regulations.  Preference with 2 KL and mammalian manufacturing ideal. 
  • Experience with mentoring and developing junior team members.
  • Ability to work in a collaborative environment with strong attention to detail and effective communication skills. Role interfaces significantly with customer service and other departments within the site.
  • Ability to manage time independently while maintaining workload in the fast-paced environment. Role requires adherence schedules and timelines.

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: R25082