Deviation Investigator Level 2

Lonza Group Ltd.; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Medical, dental, and vision insurance

Career growth

Collaborative team environment

Support life-changing therapies

Job summary

Lonza Group Ltd. is seeking a Deviations Investigator II in Portsmouth, NH, on-site, to lead and execute deviation investigations within a cGMP environment. You will mentor Level I investigators, drive CAPA development, and ensure high-quality documentation while collaborating across functions.

The role requires 3–5+ years in GMP settings, strong cGMP and data integrity knowledge, and excellence in technical writing and cross-functional communication. The schedule is Monday–Friday, 8:00am–4:30pm.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field with 3–5+ years in GMP-regulated setting.
• Strong knowledge of cGMP, GDP, and data integrity principles.
• Proven experience leading deviation investigations with RCA and CAPA development.
• Ability to manage multiple priorities and meet timelines in a fast-paced environment.
• Strong technical writing and attention to detail for compliant documentation.
• Effective communication and cross-functional collaboration; mentor junior staff suitable.

Responsibilities

• Independently lead and complete minor deviation investigations.
• Support major deviation investigations with guidance from leadership.
• Provide direction and mentorship to Level I investigators.
• Make real-time decisions on deviation containment and approach.
• Utilize RCA tools (5 Whys, fishbone, cause mapping) to drive investigations.
• Manage a moderate workload of concurrent investigations.
• Drive documentation quality with target >80% Right First Time (RFT).
• Partner cross-functionally to gather information and resolve issues.
• Develop and implement CAPAs to prevent recurrence.
• Maintain compliance with cGMP, GDP, and data integrity standards.
• Facilitate meetings, manage conflicts, and communicate with stakeholders.
• Perform additional duties as assigned.

Skills

GMP experience

Root cause analysis (RCA)

Mentoring

Technical writing

Cross-functional collaboration

MS Office proficiency

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Tools

Microsoft Office

Quality Management System (QMS)

Job description

Job Title: Deviations Investigator II Location: Portsmouth, NH (On-site)

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. This role follows a Monday-Friday, 8:00am – 4:30PM schedule.

What you will get:

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize performance
• Medical, dental, and vision insurance
• Opportunities to grow and develop your career
• A collaborative and team-focused environment
• The opportunity to support the delivery of life-changing therapies

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

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. 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. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences?