Investigation & Deviation Specialist

Role Summary

Lead and manage cGMP deviation and investigation activities within the manufacturing organization at Phibro's Chicago Heights site. Ensure 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. In periods of lower investigation activity, contribute to other technical and process-supporting capacities to improve manufacturing consistency and documentation quality.

Responsibilities

• 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.
• 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.

Qualifications

• Bachelor‚Äôs degree in Engineering, Microbiology, Biotechnology, or a related technical/scientific discipline. Relevant experience in lieu of a Bachelor‚Äôs 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.

Skills

• 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

Education

• Bachelor‚Äôs degree in Engineering, Microbiology, Biotechnology, or a related technical/scientific discipline. Relevant experience in lieu of a Bachelor‚Äôs degree will be considered.