Deviation Investigation Writer II (Biotech)

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.

Check out this video about what a career at our Portsmouth NH facility could look like for you: Your Career with Lonza in Portsmouth, NH (youtube.com)

Overview/Role Purpose:

The Deviation investigator/Initiator Level 1 is responsible for the initiation, investigation and completion of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence.  Level 1 Investigators are expected to work in a cGMP environment, have working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.  

Key Accountabilities and Duties:

• Technical writing for the educated but uninformed reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product. 
• Accurately capture immediate actions and containment of the event
• Address comments from both internal and external clients on the compiled final report.
• Gather Data from various sources across the site, perform of Root Cause Analysis to determine the most likely cause of the deviation investigation, Assessment of event for impact to SISQP, Perform Trending Analysis, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping
• Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward. 
• Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective.  
• 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,  CAPA discussions, Comments resolution
• Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviewsMinimum

Required Qualifications/Skills:

• Bachelor of Arts/Science or equivalent combination of education minimum.
• Preferred area of study:  Biochemistry, Chemical Engineering, Biology or other relevant science discipline
• 1-3 years' experience; Prior experience technical writing and in a manufacturing environment preferred
• 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. 
• Must work well on a team, and be able to trouble shoot and problem solve in a cross functional team setting. 
• Must be proactive, action oriented, and have the ability to adapt to a change. 
• Must be able to identify and flag risks in a timely manner to keep deliverables on track.  
• Must have strong communication skills both verbally and written.
• 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.
• The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. 
• Is open to and actively seeks out feedback on their performance and translates that feedback into action.