Deviation Investigator Level 2

What you will do:

• Independently lead and complete minor deviation investigations
• Support and contribute to major deviation investigations with guidance from team leadership
• Provide direction and mentorship to Level I investigators, helping to elevate team capability and consistency
• Make real-time decisions related to deviation containment and investigative approach
• Utilize a range of root cause analysis (RCA) tools (e.g., 5 Whys, fishbone, cause mapping) to drive thorough investigations
• Manage a moderate workload of concurrent investigations, ensuring timely and high-quality completion
• Drive strong documentation practices with a target of >80% Right First Time (RFT)
• Partner cross-functionally to gather information, resolve issues, and ensure alignment
• Develop and implement effective CAPAs to prevent recurrence
• Maintain compliance with cGMP, GDP, and data integrity standards
• Facilitate meetings, navigate conflict, and communicate effectively with stakeholders
• Perform additional duties as assigned
• What we are looking for:
• Bachelor’s degree in Life Sciences, Engineering, or a related field, with 3–5+ years of experience in a GMP-regulated environment (Quality Assurance or similar function)
• Strong working knowledge of cGMP, Good Documentation Practices (GDP), and data integrity principles
• Proven experience leading deviation investigations and applying root cause analysis tools (e.g., 5 Whys, fishbone, cause mapping) and CAPA development
• Ability to manage multiple priorities, make sound decisions, and deliver on timelines in a fast-paced environment
• Strong technical writing skills and attention to detail, with a focus on compliant, high-quality documentation
• Effective communication and collaboration skills, with the ability to work cross-functionally and mentor junior team members
• Demonstrated problem-solving ability and a proactive, solution-oriented mindset
• Proficiency in Microsoft Office (Excel, Word, PowerPoint); experience with biologics or mammalian processes strongly preferred

About Lonza

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field, with 3–5+ years of experience in a GMP-regulated environment (Quality Assurance or similar function)