Deviation Investigation Writer

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.

Lonza Cell and Gene Therapy Facility is the largest in the world and our facility is growing.

We are looking for professionals to grow with us as we have and exciting opportunity the Viral Vector Therapy group.

The Deviation Investigator will be responsible for the initiation, investigation of any Minor, Major, or Critical process deviations aimed at identification of root cause, determining Product Quality impact (PQI) and implementation of correct actions to prevent recurrence.

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.  Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.


* Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) 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, Cause Mapping, and 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 or 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 interviews.


* 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.

Attendance and leadership of the daily management system, and leading the deviation review board.

Key Requirements:


* Bachelor’s Degree in field of science or diploma with relevant experience


* Skilled in support in supporting pharma process investigations, technical writing and determining root cause through analysis.


* E...