Technical Investigator (Deviation Investigation), Cell & Gene Therapy

Singapore, Tuas Singapore

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 is currently looking for a Technical Investigator to join the Cell & Gene Technologies Manufacturing team. Reporting into a Section Manager, you will be 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.

Key responsibilities:

  • Perform detailed and thorough investigation for deviations, nonconformities and/ or abnormalities which occur on production floors utilizing standard methodologies e.g. 5-Whys, Ishigawa Diagrams, Failure Mode, Effect and Cause Analysis (FMECA).
  • Perform recurrence analysis for deviation and ensure the information documented within the deviation is sufficient for assessment at the Deviation Review Board (DRB)
  • Attend 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
  • Lead investigation by facilitating discussions with relevant SMEs from all departments in the course of deviation investigation
  • Interact with customers in the form of face-to-face meetings and/ or teleconferences to communicate investigation findings/ outcomes to the customer
  • 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 is factual and accurate
  • Manage appropriate system to track status of open deviations/ CAPAs to ensure timely closure
  • Ensure timely investigation and closure of all deviation reports in support of lot disposition.
  • Support customer and regulatory audits, prepare and own storyboards for deviations and present during audits
  • Work on CAPAs: creation/ revision of SOPs, Performance Measures (PMs) or any other GMP documentation triggered from deviation. Engage in the creation of content for CAPAs requiring awareness training to be delivered to Manufacturing Section Leads for cascading down to their respective teams
  • Involve in preparation of deviation metrics, to identify trends and work with Lead/ Manager to put in place measures to improve deviation life cycle, deviations reduction and any other areas of improvement
  • Participate, or lead projects as a representative of Manufacturing Technical Team

Key requirements:

  • Bachelor’s Degree in Life Sciences or related discipline
  • Prior technical knowledge in biopharmaceutical processing will be an advantage
  • Influential and ability to lead and facilitate discussions in a cross-functional investigation team
  • Strong technical communication and writing skills
  • Excellent oral presentation skills
  • Effective interaction skills with internal stakeholders, external customers and auditors
  • Advanced knowledge in navigating through Quality Management System (TrackWise), Laboratory Information Management System (LIMS) will be beneficial

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.

#LI-KG1

Reference: R34790
Similar Jobs