Compliance Engineer – 3-A Sanitary Valve Systems

Job Title: Compliance Engineer – 3-A Sanitary Valve Systems 

Job Summary:

The Compliance Engineer – 3-A Sanitary Valve Systems plays a key role in ensuring the hygienic design, regulatory compliance, and operational validation of sanitary valve systems used in fluid handling, CIP/SIP processes, and product transfer. This role is responsible for overseeing the application of 3-A Sanitary Standards, EHEDG guidelines, and FDA/USDA regulations across valve installations and designs. The engineer works cross-functionally with design, QA, maintenance, and procurement teams to ensure compliance with sanitary requirements from equipment selection through operation.

Key Responsibilities:

Sanitary Standards Compliance

• Evaluate valve system designs (e.g., mixproof, diaphragm, butterfly valves) for compliance with 3-A, EHEDG, and internal hygienic design standards.

• Review and approve equipment specifications, supplier certifications, and system layouts for hygienic compliance.

• Support validation protocols for cleanability, drainability, and food-contact material compliance.

Regulatory & Quality Documentation

• Maintain and update technical documentation for sanitary valves, including 3-A symbol authorizations, material certifications (FDA CFR 21, USP Class VI), and change control records.

• Prepare compliance reports for audits and support responses to regulatory bodies or customer inquiries.

System Qualification & Inspection

• Oversee pre- and post-installation inspections of sanitary valve systems to ensure correct orientation, weld quality, and drainability.

• Participate in commissioning, IQ/OQ, and cleaning validation related to valve-controlled systems.

Corrective Actions & Continuous Improvement

• Investigate nonconformances or audit findings related to sanitary valve systems.

• Lead or support CAPA efforts involving valve design, installation, or cleaning procedure failures.

• Recommend design improvements or valve upgrades for improved hygienic performance and regulatory alignment.

Supplier & Cross-Functional Collaboration

• Work with OEMs and valve suppliers to ensure conformance to 3-A standards and design specifications.

• Collaborate with engineering, QA, and sanitation teams to standardize valve system design and documentation practices across facilities.

Key Focus Areas:

• 3-A, EHEDG, and FDA sanitary valve system compliance

• Validation, documentation, and inspection of CIP/SIP and product-contact systems

• Regulatory readiness, audit support, and continuous improvement

• Cross-functional support for hygienic design and equipment qualification

Qualifications & Skills:

Education:

• Bachelor’s degree in Mechanical, Food, Chemical, or Biomedical Engineering

• Coursework or certifications in sanitary/hygienic design preferred

Certifications (Preferred):

• 3-A Sanitary Design or EHEDG Training

• HACCP, PCQI, or GMP compliance certifications

Experience:

• 3–6 years of experience in food, beverage, dairy, or life sciences industry

• Hands-on experience with sanitary valve system compliance, inspections, and hygienic process support

Skills:

• Strong understanding of 3-A sanitary standards and CIP/SIP valve configurations

• Proficiency with P&IDs, hygienic piping layouts, and validation documentation

• Working knowledge of FDA, USDA, and FSMA requirements related to process equipment

• Excellent communication, documentation, and problem-solving skills

• Ability to collaborate across engineering, quality, maintenance, and regulatory functions