Deviation Investigation Writer - Viral Vector

Lonza•Houston, TX

11h•Onsite

About The Position

The Deviation Investigator III – Viral Vector is responsible for leading and executing deviation investigations within a cGMP-regulated viral vector manufacturing environment. This role independently manages minor and low-to-medium severity major process deviations while supporting higher-risk investigations to identify root causes, assess product quality impact, and implement effective corrective and preventive actions (CAPAs). The position serves as a key quality partner to Manufacturing, Quality Assurance, and MSAT teams, ensuring quality records are completed accurately, compliantly, and within established timelines while supporting operational excellence and continuous improvement initiatives.

Requirements

Experience in deviation investigations, quality record management, or quality systems within a cGMP-regulated biopharmaceutical manufacturing environment.
Minimum of Associate’s in Biotechnology, Biology, Chemistry, Engineering, or another scientific discipline.
Experience performing Root Cause Analysis (RCA), CAPA development, risk assessments, and technical investigations.
Strong technical writing skills with the ability to translate complex scientific and manufacturing events into concise, compliant reports.
Ability to work independently, manage competing priorities, and meet aggressive deadlines and performance metrics.
Familiarity with cGMP quality systems and the ability to read and interpret SOPs, batch records, logs, and manufacturing documentation.
Strong organizational, analytical, problem-solving, and project management skills.
Experience interviewing personnel and collaborating across Manufacturing, Quality Assurance, and Technical Operations teams.
Excellent verbal and written communication skills with the ability to facilitate meetings and influence cross-functional teams.
Proficiency with Microsoft Office applications.

Nice To Haves

Bachelor’s degree preferred.
Experience with TrackWise is preferred.
Experience in biopharmaceutical manufacturing, viral vector manufacturing, upstream/downstream processing, fill-finish operations, or CDMO environments is preferred.
Formal training in investigations and Root Cause Analysis is preferred.

Responsibilities

Lead and independently manage deviation investigations, ensuring timely initiation, investigation, documentation, and closure of quality records.
Author clear, concise, and technically accurate investigation reports that communicate complex manufacturing and quality events to internal and external stakeholders.
Gather and evaluate data from manufacturing, laboratory, engineering, and quality systems to support comprehensive investigations.
Perform Root Cause Analysis (RCA), cause mapping, risk assessments, and trending analyses to determine the most likely cause of deviations and identify opportunities for improvement.
Assess events for impact to Safety, Identity, Strength, Quality, and Purity (SISQP) and support Product Quality Impact (PQI) determinations.
Develop and implement Corrective and Preventive Actions (CAPAs) that effectively reduce the risk of recurrence.
Manage multiple investigations, projects, and priorities simultaneously while meeting established KPIs and regulatory timelines.
Facilitate cross-functional investigation meetings, align subject matter experts on investigation strategies, and drive timely decision-making and issue resolution.
Conduct interviews with personnel and perform on-floor observations to gather facts and support investigational conclusions.
Participate in daily management meetings and provide routine updates to site leadership on investigation status, risks, and deliverables.
Interact directly with customers by providing investigation updates, supporting review meetings, resolving comments, and presenting findings and CAPA plans.
Support deviation review boards and contribute to continuous improvement of quality systems, investigation processes, and compliance programs.
Perform other duties as assigned.