Deviation Investigator Level 2

Lonza•Portsmouth, NH

1d•Onsite

About The Position

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.

Requirements

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
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.

Nice To Haves

Lean Six Sigma Green or Black Belt preferred.

Responsibilities

Responsible for the investigation and completion of deviations aimed at identification of root cause and implementation of correct actions to prevent recurrence.
Work in a cGMP environment.
Manage multiple ongoing projects concurrently.
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.
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.