Technical Investigator, Biologics Manufacturing
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.
Technical Investigator is responsible for performing deviation investigation and documenting the process and the outcome of the investigation. This includes but not limited to root cause analysis, appropriate Corrective and Preventive Actions (CAPAs) definition and product impact assessment. This role requires the individual to coordinate and collaborate with internal stakeholders such as Subject Matter Experts (SMEs) from Manufacturing, Manufacturing Science and Technology (MSAT), Engineering, Validation, Quality and any other relevant functions during the course of the investigation and to interact with external customers for presentation of the investigation findings. The individual needs to have strong technical writing skills and excellent oral presentation skills. This position reports to Senior/ Section Lead/ Manager of the Deviation Investigation Team (DIT), under Manufacturing Technical Team (MTT).
- Perform detailed and thorough investigation for deviations, non-conformities and/or abnormalities which occur on production floors
- Ensure timely investigation and closure of all deviation reports in support of lot disposition.
- The completion of a deviation report includes but not limited to root cause analysis utilizing standard methodologies e.g. 5-Whys, Ishigawa Diagrams, Failure Mode, Effect and Cause Analysis (FMECA), product/ quality impact assessment/ justification and design of appropriate CAPA(s) with effectiveness checks, where required
- Lead investigation by facilitating discussions with relevant SMEs from all departments in the course of deviation investigation, coordinate and collaborate cross-functionally to achieve completion of an investigation and the design of appropriate CAPA(s)
- Present the output from an investigation in the form of a deviation report and ensure the information populated in the deviation report, in particular the most probable root cause, impacted and associated lots is factual and accurate
- Perform recurrence analysis for deviation and ensure the information documented within the deviation is sufficient for assessment at the Deviation Review Board (DRB)
- Attend deviation clinic / DRB as Manufacturing representative to present the preliminary information for the deviations, non-conformities and/ or abnormalities and participate in the assessment/ rating of the deviation
- Attend lot disposition meeting, standup review for deviations, CAPAs and change requests and any other relevant meetings as Manufacturing representative
- Prepare and own storyboards for identified deviations to facilitate customer and regulatory audits, present and walk auditors through the deviation investigation
- Participate in customer and regulatory audits to present and walk auditors through the deviation investigation
- Work on CAPAs relating but not limited to tracking of vendor investigation report and actions, creation/ revision of SOPs, and any other GMP documentation and Effectiveness Check triggered from deviation
- Manage appropriate system to track status of open deviations/ CAPAs to ensure timely closure
- Participate, or lead projects as a representative of Manufacturing Technical Team
- Degree in Engineering (Chemical/ Biochemical) or Science (Biochemistry/ Chemistry/ Microbiology) related disciplines preferred
- Work experience in a cGMP regulated environment and prior technical knowledge in batch biopharmaceutical processing as well as manufacturing process deviation investigation
- Experience in Single-Use Technology will be beneficial
- Strong technical communication and writing skills
- Excellent oral presentation skills
- Excellent interaction skills with internal stakeholders, external customers and auditors
- Strong proficiency in standard Microsoft Office applications e.g. MS Word, Excel and PowerPoint
- Advanced knowledge in navigating through Quality Management System (TrackWise), Laboratory Information Management System (LIMS)
- Familiarity with FDA & EMA GMP and regulatory requirements
- Influential and ability to lead and facilitate discussions in a cross-functional investigation team
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.