Process Authority

Summary

The Process Authority is responsible for establishing, validating, and documenting scientifically sound thermal and aseptic processes to ensure the microbiological safety and regulatory compliance of Chobani and La Colombe shelf-stable and extended shelf-life products. The role serves as the technical authority for thermal processing, aseptic systems, and container integrity programs for canned and aseptically packaged products.
The Process Authority works closely with R&D in the development and optimization of thermal and aseptic process parameters for superior product quality, providing rapid technical evaluations and expedited turnaround of scheduled process recommendations to enable timely product trials, pilot runs, and commercialization decisions.
The Process Authority develops scheduled processes, conducts validation studies, execute the regulatory filings with the FDA, and ensures compliance with applicable regulations including 21 CFR Part 113 (Low-Acid Canned Foods) and 21 CFR Part 108 requirements.

Responsibilities

• Provide technical expertise on new and establishing aseptic and low acid canned, retort processes in support of innovation, renovation, and technical assistance.
• Develop and/or evaluate the scheduled process, determining critical factors (time, temperature, pressure, pH, formulation, fill weight, container type, etc.) to establish the minimum process required to achieve commercial sterility with optimized product quality.
• For retorted products, evaluate the formulation of products and design heat penetration studies to identify cold spot and develop the scheduled process.
• Prepare the information required for filing the schedule process with FDA for both retorted and aseptic processes and submit with FDA ensuring compliance with 21 CFR 113 (Low-Acid Canned Foods – retorted), 21 CFR 114 (Acidified foods, if applicable), 21 CFR 108 (Emergency permit control) and 21 CFR 113 Subpart B (Aseptic systems).
• Coordinate the validation of aseptic systems (UHT, A-Tanks, fillers) and the temperature distribution studies in retorts, and coordinate or conduct aseptic microbiological challenge studies, if needed. 
• Evaluate all process deviations for retorted and aseptic products to assess the impact of deviations on commercial sterility and regulatory compliance, determine and document product disposition (release, rework, or destruction), and defines required corrective actions and revalidation activities as needed.
• Ensures deviation handling complies with applicable FDA regulations (21 CFR 108, 113, and 114) and supports regulatory inspections and audits through thorough documentation and technical justification.
• Conduct risk assessments that integrate ingredients, process and packaging, as well as microbiological and controls validation and critical control operational requirements.
• The PA will coordinate employee training with outside providers on Better Process Control School as needed.

Requirements

• Bachelor’s degree in Food Science, Food Engineering, Chemical Engineering, Microbiology, or a related scientific/engineering discipline.
• 5–10 years of progressive experience in food manufacturing with direct responsibility for aseptic and/or retorted (LACF) processing
• Demonstrated experience serving as, or working under, a qualified Process Authority with proven expertise in establishing and validating thermal and aseptic processes, conducting or interpreting heat penetration and lethality studies, managing FDA process filings, evaluating and approving process deviations and product dispositions.
• Hands-on experience with aseptic processing systems, retort operations and CIP/SIP systems and sterile boundary controls, with focus on improving formulation for superior taste and sensory experience.
• Strong working knowledge of FDA regulations (21 CFR 108, 113, 114)
• Experience supporting new product development, scale-up, and commercialization
• History of participation in regulatory inspections, audits, and recall prevention activities
• Effective analytical, negotiation, problem solving, excellent communication skills, attention to details and ability to work independently
• Ability to travel up to 30% domestically.

Work Environment and/or Physical Requirements:

Chobani is an equal opportunity employer, dedicated to a policy of non-discrimination in employment without regard to race, color, religion, gender, national origin, age, disability, genetic information, veteran status or any other classification protected by federal, state and local laws and ordinances, nationally and internationally.