USFDA Compliance - Baddi Solan

An USFDA Compliance Retort Validation specialist ensures that food manufacturers meet . Food and Drug Administration (FDA) regulations for low-acid canned foods (LACF) by validating the thermal process in retorts (pressure sterilization chambers). This role involves verifying that all products receive uniform, safe heat treatment to destroy microorganisms, mapping for cold spots, conducting heat penetration studies, and maintaining detailed documentation to ensure regulatory compliance.

Location - Baddi

Required Skills and Qualifications

Education: Bachelor’s degree in Food Science, Engineering, Microbiology, or related field.

Experience: 3-8+ years in thermal processing, retort validation, or food safety regulation.

Knowledge: Expertise in FDA regulations (21 CFR Part 113), HACCP, and thermal process authority standards.

Technical: Experience with data loggers (., Ellab, Kaye) and thermal process software.

Skills: Strong technical writing, analytical, and problem-solving skills.

Food and Drug Administration (.gov)

Target Industries

Food & Beverage Manufacturing

Food Safety Consulting firms

Packaging Companies

Typical Job Description & Responsibilities

Thermal Process Validation: Systematically test and verify that retort heat treatments consistently achieve commercial sterility.

Retort Mapping & Validation: Conduct temperature distribution studies to ensure uniform heat mapping, identifying cold spots in autoclaves/retorts.

Heat Penetration Studies: Measure how quickly heat reaches the coldest point of a product/package to establish the necessary scheduled process (F0 value).

Regulatory Documentation: Prepare documentation (such as FCE/SID filings) that complies with FDA 21 CFR Part 11 and 21 CFR 113 for low-acid canned foods.

Protocol Development: Author, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

Deviation Handling: Investigate and resolve deviations in thermal processing, implementing corrective actions (CAPA).

Collaboration: Work with production and QA teams to ensure compliance with cGMP (current Good Manufacturing Practices).

• Experience

  2 - 3 Years

• No. of Openings

  2

• Education

  Graduate

• Role

  Compliance Specialist

• Industry Type

  FMCG / Retail / Food / Beverages

• Gender

  Male

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office

• Face interview location

  Chandigarh