Deviation Investigator Level 2
Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.
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.
What you will do:
The Deviation Investigator Level II is responsible for the investigation and completion of deviations aimed at identification of root cause and implementation of correct actions to prevent recurrence. Level II Investigators are expected to work in a cGMP environment, have working knowledge of mammalian processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.
Draws from relevant experience to aid in real-time decisions for deviation containment and investigative response.
Provide direction on internal deviation approach for Level 1 investigators and, as this occurs, transfer knowledge to the personnel involved to elevate expertise of the teams.
Ability to manage moderate workloads with consistent on-time delivery.
Independent completion of minor deviation investigations.
Completion of major deviation investigations with assistance from team leads.
Experience using multiple root cause analysis tools such as 5-why and fishbone. Continued development for utilization of advanced RCA tools such as cause mapping
Work to achieve >80% Right First Time on customer deviation reviews.
Drive for effective CAPA such that deviations do not recur.
Perform other duties as assigned.
What we are looking for:
Bachelor’s degree in biotechnology, Biology, Chemistry, or related scientific discipline, or equivalent industry experience (2–4 years) in a cGMP-regulated environment.
Demonstrated experience conducting structured deviation investigations with clear root cause identification and effective, sustainable CAPA implementation.
Working knowledge of mammalian cell culture processes and biopharmaceutical manufacturing operations.
Proficiency in root cause analysis methodologies (e.g., 5-Why, Fishbone) with developing capability in advanced problem-solving tools such as cause mapping; Lean Six Sigma Green or Black Belt preferred.
Strong technical writing skills with the ability to clearly articulate complex investigations, risk assessments, and compliance justifications.
Ability to independently manage multiple investigations simultaneously while maintaining quality, timeliness, and compliance standards.
Demonstrated sound decision-making skills, applying risk-based thinking and considering operational, quality, and regulatory impact.
Effective cross-functional collaborator with strong meeting facilitation and conflict resolution skills.
Exhibits a questioning attitude and consistently applies Error Prevention System (EPS) principles such as three-way communication and proactive risk identification.
Highly organized with strong planning, prioritization, and execution capabilities to drive right-first-time investigation outcomes.
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? Apply now.