Deviation Investigation Level 3 - Night Shift

Responsibilities

• Key responsibilities include:
• Lead and independently execute complex and high-impact deviation investigations
• Provide technical guidance and strategic direction on investigation approach across teams
• Mentor and support Level I and II investigators, building team capability and consistency
• Make critical, real-time decisions related to deviation containment and investigative strategy
• Apply advanced root cause analysis (RCA) tools (e.g., 5 Whys, fishbone, cause mapping) to drive thorough and effective investigations
• Manage moderate to high volumes of concurrent investigations with consistent on-time delivery
• Take ownership of in-progress or escalated investigations with minimal oversight
• Drive high-quality documentation and maintain a target of >80% Right First Time (RFT)
• Ensure effective CAPA development and implementation to prevent recurrence
• Partner cross-functionally to resolve complex issues and influence outcomes
• Share knowledge and best practices to strengthen investigation performance and build sustainable, high-performing teams
• Identify opportunities for continuous improvement in investigation processes and execution
• Maintain strict adherence to cGMP, GDP, and data integrity standards
• Perform additional duties as assigned

Requirements

• Bachelor's degree in Life Sciences, Engineering, or a related field, with 5-7+ years of experience in a GMP-regulated environment (Quality Assurance or similar function)
• Deep knowledge of cGMP, Good Documentation Practices (GDP), and data integrity principles
• Demonstrated expertise leading complex deviation investigations and developing effective CAPAs
• Advanced proficiency with root cause analysis tools (e.g., 5 Whys, fishbone, cause mapping) and ability to coach others in their use
• Strong ability to manage competing priorities, make sound, risk-based decisions, and deliver results in a fast-paced environment
• Excellent technical writing skills with a focus on clarity, compliance, and quality
• Strong communication, facilitation, and influencing skills, with experience mentoring or leading others
• Proficiency in Microsoft Office (Excel, Word, PowerPoint); experience with biologics or mammalian manufacturing processes strongly preferred
• About Lonza
• Ready to shape the future of life sciences?

Benefits

Additional Information

Deviation Investigation Level 3 - (Night Shift) Location: This position is based in our Portsmouth, NH office. This is a 3rd shift position operating on a 12-hour rotating schedule (7:00 PM - 7:00 AM). The schedule follows a rotating pattern of Monday-Tuesday workdays, Wednesday-Thursday off, Friday-Sunday workdays, and continues a biweekly rotation. What you will get: Below you will find a comprehensive summary of the benefits package we offer: 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). Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Lonza? Share your experience