Senior Biotechnology Investigator
1 week ago
Company Overview
Lonza is a leading global player in the life sciences industry, with a strong presence across three continents. Our team of talented individuals works together to develop innovative solutions that help businesses improve people's lives.
About the Role
The Senior Biotechnology Investigator will play a key role in investigating deviations and nonconformities on production floors. This includes performing detailed root cause analysis, defining appropriate Corrective and Preventive Actions (CAPAs), and assessing product impact.
Key Responsibilities:
- Conduct thorough investigations for deviations, nonconformities, and abnormalities using standard methodologies such as 5-Whys, Ishigawa Diagrams, and Failure Mode, Effect and Cause Analysis (FMECA).
- Analyze recurrence data to ensure sufficient information is documented for assessment at the Deviation Review Board (DRB).
- Represent Manufacturing at DRB meetings to present preliminary information and participate in deviation assessment.
- Lead investigation discussions with relevant SMEs from all departments.
- Communicate investigation findings and outcomes to customers through face-to-face meetings or teleconferences.
- Cross-functionally collaborate to complete investigations and design CAPAs.
- Present deviation reports with factual and accurate information.
- Manage systems to track open deviations/CAPAs and ensure timely closure.
- Support customer and regulatory audits by preparing storyboards and presenting during audits.
Required Skills and Qualifications
- Degree in Engineering (Chemical/Biochemical) or Science (Biochemistry/Chemistry/Microbiology) related disciplines.
- Experience in cGMP regulated environments 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 Microsoft Office applications (MS Word, Excel, PowerPoint).
- Familiarity with FDA & EMA GMP and regulatory requirements.
About Lonza
Lonza respects and protects its people and environment, striving for business success while maintaining ethics. We offer challenging roles, creativity, and the satisfaction of improving lives worldwide. Our estimated salary range for this position is $80,000 - $110,000 per year.
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