Deviation Investigator Level 2

Lonza Group Ltd.; Portsmouth (NH); Presencial; USD 80.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision insurance

Career development

Inclusive workplace

Performance rewards

Team-focused culture

Descripción de la vacante

Lonza Group Ltd. is seeking a Deviations Investigator II to lead and execute deviation investigations in a cGMP environment at our Portsmouth, NH site. The role focuses on root cause analysis, CAPA implementation, and mentoring junior investigators to enhance investigation quality.

The position emphasizes independent work, cross-functional collaboration, and maintaining compliant documentation practices in a fast-paced setting with a Monday–Friday schedule and on-site operations.

Formación

• Bachelor’s degree in Life Sciences, Engineering, or a related field; 3–5+ years in a GMP-regulated environment.
• Strong working knowledge of cGMP, GDP, and data integrity.
• Proven experience leading deviation investigations and applying RCA tools and CAPA development.
• Ability to manage multiple priorities and meet timelines in a fast-paced setting.
• Strong technical writing and cross-functional collaboration skills.

Responsabilidades

• Independently lead and complete minor deviation investigations.
• Support major deviation investigations with guidance from leadership.
• Mentor Level I investigators to elevate team capability.
• Make real-time containment and investigation decisions.
• Apply RCA tools to drive thorough investigations and actionable CAPAs.

Conocimientos

Root cause analysis

CAPA development

GMP knowledge

Documentation

Mentoring

Microsoft Office

Educación

Bachelor’s degree in Life Sciences/Engineering

Herramientas

Microsoft Office

Descripción del empleo

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.

Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year.

Lonza is a place where people can make a unique impact, grow their careers and belong.

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow.

Join us. Be you.