Senior Deviation Investigation Writer

United States, Portsmouth (New Hampshire)

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.

The Senior Deviation Investigation Investigator is responsible for the initiation, investigation of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence. In this role, you will be expected to work in a cGMP environment, have a high working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently as well as mentor and train others within the group, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.        

Key Responsibilities:

  • Technical writing for the educated but uninformed reader, translating difficult and complex scientific events into a brief and cohesive report as a finished product.  Addressing comments from both internal and external clients on the compiled filed report.
  • Gathering data from various sources across the site, lead and perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation, Assessment of event for impact to SISQP, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Cause Mapping, Interviewing
  • Management of multiple projects and timelines concurrently.  Participation in the Daily Management meetings to update leadership on current deviation statuses
  • Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, Alignment meetings, facilitated reviews,  CAPA discussions, Comments resolution
  • Meeting facilitation and participation, aligning internal team and area subject matter experts on an agreed to investigational path forward.  
  • Complex conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objectives

Key Requirements:  

  • Bachelor of Arts/Science or equivalent combination of education minimum.
  • Preferred area of study: Biochemistry, Chemical Engineering, Biology or other relevant science discipline
  • Substantial experience technical writing; in a biotech/life science manufacturing environment preferred.
  • Experience participating in or leading investigations.
  • Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.
  • Work well on a team, and be able to trouble shoot and problem solve in a cross functional team setting.
  • Ability to be proactive, action oriented, and have the ability to adapt to a change.
  • Able to identify and flag risks in a timely manner to keep deliverables on track.
  • Proven logic and decision making abilities, critical thinking skills
  • Strong written and verbal communication skills are required. Ability to read and comprehend complex subjects. Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.

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: R31686
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