Process Authority Specialist

Job Summary:

The Process Authority applies knowledge of product characteristics, processing equipment, and validation methodologies to design, execute, and evaluate studies such as heat penetration, heat distribution, thermal process validations, and microbiological challenge studies. The role is responsible for analyzing study data, identifying critical process factors, and developing recommendations to support safe and compliant manufacturing processes.

The Process Authority works closely with Lab+, research teams, and clients to develop and optimize thermal process studies, providing technical evaluations and recommendations that support product trials, pilot runs, regulatory requirements, and commercialization efforts.

Essential Responsibilities:

• Lead client discussions related to thermal process validation studies and technical requirements.
• Design and develop protocols, proposals, and reports for thermal process validation projects.
• Conduct and/or oversee thermal validation studies, including heat penetration and heat distribution studies.
• Evaluate study data and provide technical recommendations related to process safety and compliance.
• Collaborate with research scientists, laboratory teams, and internal stakeholders on technical projects.
• Support client projects requiring coordination across multiple teams and resources.
• Prepare clear, accurate technical reports and presentations summarizing validation results.
• Conduct on-site validations and provide technical support during client activities.
• Support advanced technical studies, including process validations, product evaluations, and regulatory documentation.
• Provide technical support to commercial teams and clients regarding food safety and process validation topics.

Qualifications:

• Bachelor's degree in Food Science, Microbiology, Chemistry, Engineering, or related scientific discipline.
• 3–6 years of relevant experience in food processing, thermal validation, food safety, or related technical roles.
• Experience working with or supporting qualified Process Authority activities, including thermal process validation, heat penetration studies, lethality evaluations, or process recommendations.
• Working knowledge of FDA regulations, including 21 CFR 108, 113, and 114.
• Experience supporting new product development, process scale-up, and commercialization activities.
• Familiarity with ISO 17025 accreditation requirements preferred.
• Experience with regulatory documentation, audits, inspections, or process compliance activities preferred.
• Strong analytical, problem-solving, and decision-making skills with attention to detail.
• Excellent verbal and written communication skills with the ability to interact effectively with clients and technical teams.
• Proficiency with Microsoft Office Suite applications (Excel, Word).
• Experience with LIMS systems is a plus.

Physical Demands/Work Environment:

• Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens.
• Use of PPE in the laboratory is required
• Noise level varies from quiet to loud.
• The temperature varies from hot to cold.
• The environment is interactive and fast-paced.
• Occasionally lift and/or move up to 25 pounds.

Schedule: Monday-Friday, 8:00 am-4:30 pm