Deviation Investigation Level 2 - Night Shift

What You Will Get

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

What You Will Do

The Deviation Investigator II is responsible for leading and executing deviation investigations within a cGMP environment, with a focus on identifying root cause and implementing effective corrective and preventive actions (CAPAs). This role operates with a higher level of independence and plays a key part in mentoring junior investigators and driving investigation quality.

• 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.

About the Role

• 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.
• Able 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.

Requirements

At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.