Deviation Investigation Writer - Viral Vector

About the role

This is an on-site position located in Houston, TX, available Monday through Friday, standard office hours (approximately 8:00 a.m. to 5:00 p.m.). The Deviation Investigator III – Viral Vector is responsible for leading and executing deviation investigations within a cGMP-regulated viral vector manufacturing environment.

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.

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. Bachelor’s degree preferred.
• 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. 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.

Benefits

• Competitive salary position.
• 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).

Pay

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Schedule

Standard office hours (approximately 8:00 a.m. to 5:00 p.m.), Monday through Friday.