Deviation Investigator Level 2

Lonza; Portsmouth (NH); Vor Ort; Confidential; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

Opportunities to grow and develop your

Collaborative and team-focused culture

Zusammenfassung

Lonza Portsmouth is seeking a Deviations Investigator II to lead deviation investigations in a cGMP environment and mentor junior staff. The role focuses on root-cause analysis and CAPA development to prevent recurrence, with strong emphasis on documentation and cross-functional collaboration.

The position requires a Bachelor's degree in Life Sciences or Engineering with 3–5+ years in GMP settings and proficiency in GDP and data integrity. On-site at Portsmouth, NH, Mon-Fri, 8:00am–4:30pm.

Qualifikationen

• Bachelor's degree required in Life Sciences, Engineering, or related field.
• 3–5+ years in a GMP-regulated environment (Quality Assurance or similar).
• Strong knowledge of cGMP, GDP, and data integrity principles.

Aufgaben

• 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, elevating team capability.
• 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.
• Drive documentation with a target of >80% Right First Time (RFT).
• Partner cross-functionally to gather information and resolve issues.
• Develop and implement effective CAPAs to prevent recurrence.
• Maintain compliance with cGMP, GDP, and data integrity standards.
• Facilitate meetings and communicate effectively with stakeholders.

Kenntnisse

Bachelors in Life Sciences/Engineering

Ausbildung

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

Jobbeschreibung

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.