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Phibro Animal Health · 3 hours ago

Investigation & Deviation Specialist

Chicago Heights, IL

Full-time

Onsite

Entry, Mid Level

$74K/yr - $90K/yr

2+ years exp

Phibro Animal Health Corporation is a global organization specializing in animal health and nutrition. The Investigation & Deviation Specialist will lead cGMP deviation and investigation activities, ensuring compliance and driving operational excellence within the manufacturing organization.

AgricultureFarmers MarketFood Processing

H1B Sponsor Likely

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

Qualification

CGMP complianceRoot cause analysisTechnical writingPharmaceutical manufacturingFermentation processesQuality Management SystemsAnalytical skillsProblem-solvingCross-functional collaborationAdaptability

Required

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

Ability to work independently, manage multiple priorities, and collaborate cross-functionally

Preferred

Knowledge of fermentation or biologics processes preferred

Familiarity with electronic Quality Management Systems (TrackWise, Veeva, etc.) and data analysis tools

Company

Phibro Animal Health

Phibro Animal Health Corporation is dedicated to helping meet the growing demand for animal protein.

Founded in 2000

Teaneck, New Jersey, USA

1001-5000 employees

http://www.pahc.com/

H1B Sponsorship

Phibro Animal Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2025 (1)