Deviation Investigator Level 2

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

Benefits offered by this job

Agile culture

Inclusive workplace

Competitive compensation

Medical/dental/vision

Career growth

Team collaboration

Life-changing therapies

Job summary

Lonza in Portsmouth, NH (onsite) seeks a Deviations Investigator II to lead and execute deviation investigations in a cGMP environment, focusing on root cause and CAPA implementation. The role includes mentoring junior investigators and driving investigation quality.

Typical schedule is Monday–Friday, 8:00am–4:30pm, with opportunities to influence cross-functional teams and improve regulatory documentation practices. Join a collaborative, ethical workplace delivering life-changing therapies.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field; 3–5+ years in a GMP-regulated environment.

Responsibilities

• 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
• Make real-time decisions related to deviation containment and investigative approach
• Utilize RCA tools (5 Whys, fishbone, cause mapping) to drive thorough investigations
• Manage a moderate workload of concurrent investigations with timely, high-quality completion
• Develop and implement effective CAPAs to prevent recurrence
• Maintain compliance with cGMP, GDP, and data integrity standards
• Facilitate meetings and communicate with stakeholders
• Perform additional duties as assigned

Skills

Deviation investigations

Root cause analysis

CAPA development

cGMP knowledge

GDP knowledge

Data integrity

Technical writing

Cross-functional collaboration

Mentoring

Education

Bachelor's degree in Life Sciences/Engineering

Tools

Microsoft Office

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.