Deviation Investigation Writer

United States, Portsmouth (New Hampshire)

The Deviation investigator / Initiator is responsible for the initiation, investigation of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence. The investigator is seen as an investigational technical expert. Investigator / Initiators are expected to work in a Good Manufacturing Practice (cGMP) environment, have an expert level working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently as well as have excellent meeting facilitation and conflict resolution skills, a professional and expert technical writing capability, be action oriented, and be compliant minded while performing investigations.

Must be within (or able to relocate to) commuting range of our Portsmouth NH facility, as regular on-site presence is required for this role 

Key Responsibilities:

  • Technical writing for the educated but uninformed reader, translating very complex and challenging scientific events into a brief and cohesive report as a finished product.
  • Gathering Data from various sources across the site, lead and perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, Assessment of event for impact, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance and leading of Risk Assessments, Causing Mapping, Interviewing.
  • Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner. 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, Corrective and Preventative Actions (CAPA) discussions, Comments resolution.
  • Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interview.
  • Meeting Facilitation and participation, aligning internal review 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 of varying difficulty, inclusive of complex technical topics.

Key Requirements:

  • Bachelor of Arts/Science required. Preferred area of study: Biochemistry, Chemical Engineering, Biology or other relevant science discipline
  • Strong working experience with technical writing and in a manufacturing environment required. Experience in biotechnology industry. Prior experience working in a manufacturing environment or troubleshooting manufacturing related issues.
  • 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.
  • 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: R50675