Technical Investigator
3 days ago
Lonza is a global leader in life sciences, operating across three continents. 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.
We are the 1st biologics contract manufacturer in the world, offering exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience.
Key Responsibilities- Perform detailed and thorough investigations for deviations, nonconformities, and/or abnormalities on production floors using standard methodologies.
- Perform recurrence analysis for deviations and ensure the information documented within the deviation is sufficient for assessment at the Deviation Review Board.
- Attend DRB as Manufacturing representative to present preliminary information for deviations, non-conformities, and/or abnormalities and participate in the assessment/rating of the deviation.
- Lead investigations 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 systems to track the 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.
- Degree in Engineering (Chemical/Biochemical) or Science (Biochemistry/Chemistry/Microbiology) related disciplines.
- Work experience in a cGMP regulated environment and prior technical knowledge in batch biopharmaceutical processing as well as manufacturing process deviation investigation.
- Strong technical communication, writing skills, and presentation skills.
- Excellent interaction skills with internal stakeholders, external customers, and auditors.
- Proficiency in standard Microsoft Office applications (e.g., MS Word, Excel, and PowerPoint).
- Familiarity with FDA & EMA GMP and regulatory requirements.
- Influential and ability to lead and facilitate discussions in a cross-functional investigation team.
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.
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