On-Site Deviation Investigator II: Root Cause & CAPA

Lonza; Houston (TX); On-site; Confidential; Full time

Job summary

Lonza in Houston, TX seeks a Deviation Investigator Level II to lead root cause investigations and implement corrective actions ensuring safe medicine manufacturing. This site-based role emphasizes close collaboration and hands-on data gathering on the manufacturing floor with strong cross-functional communication.

You will manage multiple investigations, run RCA tools, assess SISQP impacts, and drive timely closure of CAPAs to prevent recurrence and safeguard product quality.

Qualifications

• Bachelor's degree in a scientific or engineering discipline (or equivalent practical experience).
• Proven experience initiating and leading deviation investigations within a regulated cGMP manufacturing environment.
• Demonstrated proficiency in Root Cause Analysis (RCA) tools (e.g., 5 Whys, Fishbone, Cause Mapping) and SISQP impact assessments.
• Ability to work comfortably on the active manufacturing floor for observational studies and interviews.
• Strong project management and time-management skills to lead multiple concurrent timelines and drive cross-functional conflict resolution.
• Excellent written and verbal communication skills, with experience facilitating cross-functional meetings and presenting to clients or internal stakeholders.

Responsibilities

• Initiate, investigate, and complete Minor and low/medium severity Major process deviations unassisted; complete high severity Major and Critical deviations under supervision to identify root causes and prevent recurrence.
• Gather data from site-wide sources, perform Root Cause Analysis (RCA), assess events for impact to Safety, Identity, Strength, Quality, and Purity (SISQP), run trending analyses, and conduct risk assessments and cause mapping.
• Manage multiple project timelines concurrently, adhere to standard execution schedules, and escape blockers appropriately for timely resolution.
• Work directly on the manufacturing floor to gather data, observe processes, and conduct associate interviews.
• Facilitate cross-functional alignment meetings, CAPA discussions, and comment resolutions while actively participating in or leading daily management updates and Deviation Review Boards (DRB).
• Routinely interact with customers by compiling presentations to communicate current investigation statuses and align on technical paths forward.
• Perform other duties as assigned.

Skills

Root Cause Analysis

Project Management

Communication

Manufacturing Floor Experience

Data Gathering & Analysis

Education

Bachelor's degree in a scientific or engineering discipline

Tools

5 Whys

Fishbone Diagram

Cause Mapping

Job description

Lonza in Houston, TX seeks a Deviation Investigator Level II to lead root cause investigations and implement corrective actions ensuring safe medicine manufacturing. This site-based role emphasizes close collaboration and hands-on data gathering on the manufacturing floor with strong cross-functional communication.

You will manage multiple investigations, run RCA tools, assess SISQP impacts, and drive timely closure of CAPAs to prevent recurrence and safeguard product quality.