Biopharmaceutical Investigator
4 weeks ago
At Lonza, we're committed to delivering high-quality products and services that make a positive impact on people's lives. As a Technical Investigator, you'll play a critical role in ensuring the quality and integrity of our biologics manufacturing processes.
The Technical Investigator is responsible for investigating deviations and nonconformities in our manufacturing processes. This includes performing root cause analysis, defining Corrective and Preventive Actions (CAPAs), and assessing product impact.
Key responsibilities include:
- Investigating deviations and nonconformities using standard methodologies such as 5-Whys and Failure Mode, Effect and Cause Analysis (FMECA)
- Performing recurrence analysis and ensuring sufficient information is documented for assessment at the Deviation Review Board (DRB)
- Attending DRB as a Manufacturing representative to present preliminary information and participate in assessment/rating of deviations
- Leading investigations by facilitating discussions with relevant SMEs from all departments
- Interacting with customers to communicate investigation findings/outcomes
- Coordinating and collaborating cross-functionally to achieve completion of investigations and design of CAPAs
- Presenting output from investigations in the form of deviation reports and ensuring information is factual and accurate
- Managing systems to track status of open deviations/CAPAs and ensuring timely closure
- Supporting customer and regulatory audits; preparing and owning storyboards for deviations and presenting during audits
Key requirements include:
- 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 and 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, 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're committed to making a meaningful difference in people's lives. We believe that our greatest scientific solution is talented people working together to devise ideas that help businesses help people. If you're passionate about delivering high-quality products and services, we want to hear from you.
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