Position Details

The Investigation & Deviation Specialist is responsible for leading and executing cGMP deviation and investigation activities within the manufacturing organization. This technically skilled professional ensures that events are thoroughly assessed, root causes are accurately identified, and effective corrective and preventive actions (CAPAs) are implemented to maintain regulatory compliance and drive operational excellence.

While the primary focus of this role is deviation and investigation management, the Specialist will also contribute in other technical and process-supporting capacities during periods of lower investigation activity — leveraging engineering and analytical skills to improve manufacturing consistency, documentation quality, and overall process understanding.

This position requires a technically trained individual (scientific discipline or equivalent engineering background) with excellent technical writing skills, a strong grasp of pharmaceutical manufacturing requirements, and preferably experience in fermentation-based pharmaceutical operations.

Key Responsibilities

**Deviation & Investigation Management (Primary Focus)**

• Lead, author, and manage manufacturing deviations and investigations, ensuring compliance with cGMP, site procedures, and corporate standards.
• Conduct structured root cause analyses (5-Why, Fishbone, Fault Tree, Human Error Analysis) to identify true root causes and define effective CAPAs.
• Write clear, concise, and scientifically sound investigation reports that withstand regulatory review.
• Collaborate cross-functionally with Quality, Process Technical/CI, Engineering, and Operations to ensure timely and thorough closure of all investigations.
• Track, trend, and communicate investigation metrics to site leadership and support reduction of repeat deviations. Work cross-functionally with Engineering and Production teams to help steer process improvements.
• Participate in internal audits and external inspections as a subject matter expert for the investigation process.

Secondary Responsibilities

**Secondary Responsibilities (as workload permits)**

• Provide technical writing support for protocols, risk assessments, change controls, and manufacturing documentation.
• Assist in deviation reduction initiatives, human error analyses, and procedure optimizations.
• Partner with manufacturing to improve data integrity, record-keeping, and alignment of shop-floor practices with cGMP expectations.
• Contribute to training initiatives aimed at strengthening root cause and investigation competencies across departments.
• Participate in special projects such as technology transfers, new equipment qualification, or process robustness studies.

Education & Experience

• Bachelor’s degree in Engineering, Microbiology, Biotechnology, or a related technical/scientific discipline. Relevant experience in lieu of a Bachelor’s degree will be considered.
• Minimum 2-5 years of experience in a cGMP pharmaceutical or biotechnology manufacturing environment.
• Demonstrated experience in authoring and leading investigations and CAPAs.
• Exceptional technical writing and documentation skills.
• Strong analytical and problem-solving ability with a holistic understanding of manufacturing systems.
• Knowledge of fermentation or biologics processes preferred.
• Familiarity with electronic Quality Management Systems (TrackWise, Veeva, etc.) and data analysis tools.
• Ability to work independently, manage multiple priorities, and collaborate cross-functionally.

Competencies

• Technical acumen and data-driven mindset
• Strong technical writing and verbal communication skills
• Cross-functional collaboration and influencing ability
• Quality and compliance focus
• Adaptability and initiative to add value beyond primary scope