Today, Lonza is a global leader in life sciences operating across five 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 currently seeking an experience MSAT Process Engineer II to join their team in Portsmouth, NH.
POSITION: MSAT Process Engineer II
JOB LOCATION: 101 International Drive, Portsmouth, NH 03801 [and various unanticipated locations throughout the U.S.; may work from home]
MSAT Process Engineer II needed by Lonza Biologics, Inc. in Portsmouth, NH [and various unanticipated locations throughout the U.S.; may work from home] to perform all functions associated with process transfer and process support. Develop process understanding. Perform gap analysis/FMEA. Generate process models. Author/review Process Descriptions and Batch Records. Perform process monitoring including manufacturing data summary and analysis and data presentation. Author/review change controls. Author campaign summary reports. Perform activities for lot release including assess deviations and process changes. Provide guidance on process transfer and support activities to junior members of the team. Assess major deviations including those that impact product quality. Identify potential root causes using a systematic approach. Apply experience performing root cause analysis. Perform or understand all types of complex data analysis such as interpreting process trends and data in the context of prior runs. Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls independently, and author/review/modify the corresponding templates. Assess change controls for impact of any change to the process, equipment, or procedures that can affect process performance and product quality. Support documentation preparation for regulatory purposes. Represent MSAT on project teams and interface with customer technical and quality representatives. Represent MSAT on internal teams. Participate in customer and regulatory audits. Follow all training and policy guidelines established for the facility as well as all cGMP requirements. Ensure employee training profile is always up to date by regular monitoring of training lists and complete all training in a timely fashion. Apply experience in aseptic technique and mammalian cell culture. Apply computer skills including Word, Excel, Outlook, and PowerPoint.
MINIMUM REQUIREMENTS: Requires a Bachelor’s degree, or foreign equivalent degree, in Biological Sciences, Biomedical/Chemical Engineering, or Bioengineering and 3 years of experience in the job offered or 3 years of experience in a related occupation applying experience in aseptic technique and mammalian cell culture; and applying computer skills including Word, Excel, Outlook, and PowerPoint.
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.