Deviation Investigation Writer - Viral Vector (Biopharmaceutical Manufacturing)

Location: On-site in Houston, Texas, United States; Monday through Friday, approximately 8:00 a.m. to 5:00 p.m.

Company

hirify.global is a global life sciences manufacturing company with more than 30 sites across five continents, supporting the development and production of medicines and therapies.

What you will do

• Lead and independently manage minor and low-to-medium severity major deviation investigations from initiation through compliant closure.
• Write technically accurate investigation reports covering complex manufacturing and quality events.
• Collect and evaluate data from manufacturing, laboratory, engineering, and quality systems.
• Perform root cause analysis, cause mapping, risk assessments, trending, SISQP assessments, and product quality impact determinations.
• Develop CAPAs, facilitate cross-functional investigation meetings, interview personnel, and conduct on-floor observations.
• Provide investigation updates to site leadership and customers, support review meetings and deviation review boards, and contribute to quality-system improvements.

Requirements

• Experience with deviation investigations, quality records, or quality systems in a cGMP-regulated biopharmaceutical manufacturing environment.
• At least an Associate’s degree in Biotechnology, Biology, Chemistry, Engineering, or another scientific discipline; a Bachelor’s degree is preferred.
• Experience with root cause analysis, CAPA development, risk assessments, and technical investigations.
• Strong technical writing, analytical, organizational, problem-solving, communication, and project management skills.
• Ability to work independently, manage competing priorities, meet deadlines and KPIs, and collaborate with Manufacturing, Quality Assurance, and Technical Operations.
• Familiarity with cGMP quality systems and manufacturing documentation, plus proficiency with Microsoft Office applications.

Nice to have

• Experience with TrackWise, viral vector manufacturing, upstream or downstream processing, fill-finish operations, or CDMO environments.
• Formal investigation and root cause analysis training.
• Bachelor’s degree in a relevant scientific or engineering discipline.

Culture & Benefits

• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Life insurance and short- and long-term disability insurance.
• Paid time off and employee assistance programs.
• Collaborative, accountable, excellence-focused, and inclusive work environment.