Sanitary Design Specialist – 3-A/ASME BPE

The Senior Sanitary Design Specialist – 3-A/ASME BPE leads the development and validation of complex hygienic equipment and piping systems, ensuring strict compliance with 3-A Sanitary Standards and ASME BPE guidelines. This role involves leading design projects, mentoring junior engineers, engaging in customer-facing technical reviews, and driving sanitary design innovation for high-performance systems in regulated industries such as biotechnology, food & beverage, pharmaceuticals, and personal care.

This individual serves as a subject matter expert in hygienic design and works closely with QA, manufacturing, and project engineering to ensure equipment is cleanable, compliant, and built to last.

Key Focus Areas:

1. Hygienic Equipment and Process System Design Leadership

2. Advanced Application of 3-A and ASME BPE Standards

3. Cross-Functional Oversight from Concept Through Commissioning

4. Mentorship and Sanitary Engineering Best Practices Development

5. Client Interaction and Regulatory Compliance Assurance

Key Responsibilities:

1. Sanitary Design Leadership

• Lead the hygienic design of process equipment, piping systems, valve networks, and skids with focus on cleanability, sterility, and ergonomics.

• Ensure proper slope, minimum dead leg configurations, and hygienic weld joint locations in all designs.

• Drive implementation of best practices for CIP/SIP systems integration.

2. Regulatory & Standards Compliance

• Serve as in-house authority on 3-A, ASME BPE, and EHEDG guidelines.

• Oversee compliance documentation, audits, and validation for both internal and client-facing design approvals.

• Approve critical designs and validate component/material selections to ensure regulatory conformity.

3. Component and Material Strategy

• Lead specification of hygienic valves, instrumentation, tanks, fittings, and tubing for high-purity and food-grade systems.

• Work with vendors to validate 3-A, FDA, and USP Class VI compliance.

• Provide guidance on surface finish requirements, material compatibility, and fabrication tolerances.

4. Project Engineering & Collaboration

• Collaborate with project managers, fabricators, QA/QC, and field engineers to ensure designs are executed as intended.

• Review manufacturing documents (P&IDs, layout drawings, isometrics) and provide approvals.

• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning activities.

5. Mentorship and Technical Oversight

• Mentor junior and mid-level design engineers on hygienic design practices, standards, and documentation.

• Develop internal design standards, templates, and technical SOPs related to sanitary design.

• Contribute to R&D for design improvement and innovation in sanitary equipment.

Qualifications:

• Bachelor’s or Master’s degree in Mechanical Engineering, Bioengineering, or Process Engineering.

• Minimum 7–10 years of experience in sanitary/hygienic design for food, pharma, or biotech industries.

• Deep knowledge of 3-A Sanitary Standards and ASME BPE design principles and documentation.

Preferred Skills:

• Proficiency in 3D CAD tools such as SolidWorks, AutoCAD Plant 3D, or Revit.

• Experience with process equipment design including skids, tanks, cleanrooms, and sterile piping.

• Understanding of surface finish measurements, hygienic welding, and orbital welding standards.

• Familiarity with validation protocols (IQ/OQ) and GMP documentation.

Core Competencies:

• Leadership in hygienic design execution

• Regulatory and standard interpretation (3-A, ASME BPE)

• Mentorship and technical coaching

• Cross-functional and customer collaboration

• Precision and design integrity under regulated environments