The Director – Process Heating and Sanitation Systems is responsible for the design, operation, maintenance, and optimization of all systems related to process heating (including steam, hot water, heat exchangers) and sanitation systems (including CIP, SIP, and process water treatment). This role ensures these critical systems support manufacturing processes in compliance with GMP, FDA, USDA, or other regulatory standards, while optimizing for safety, efficiency, and reliability. The Director will lead cross-functional teams and collaborate with operations, quality, and engineering to implement best practices and continuous improvement in process hygiene and thermal systems.
Oversee operation and performance of process heating systems, including:
Clean steam generation
Hot water systems
Heat exchangers
Thermal oil systems (if applicable)
Manage design and performance of sanitation systems such as:
CIP (Clean-in-Place)
SIP (Steam-in-Place)
Sanitary water loops (WFI, PW)
Caustic/sanitizing agent delivery and recovery systems
Ensure all systems are designed and operated in accordance with GMP, FDA, USDA, 3-A Sanitary Standards, and internal quality requirements.
Lead and support validation, commissioning, and qualification (IQ/OQ/PQ) of sanitary and heating systems.
Maintain detailed documentation of process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and sanitation protocols.
Develop and manage preventive and predictive maintenance programs for heating and sanitation equipment.
Coordinate with utilities and maintenance teams to ensure uptime, rapid response to failures, and overall system reliability.
Lead root cause analysis and corrective actions (RCA/CAPA) for system failures or contamination events.
Lead capital and infrastructure projects related to the installation, upgrade, or expansion of process heating and sanitation systems.
Review design specifications and provide technical oversight during system integration with production lines.
Ensure systems are optimized for energy efficiency, cleaning efficiency, and chemical usage.
Ensure compliance with OSHA, ASME, NFPA, and local safety regulations in the operation of high-temperature and pressurized systems.
Oversee implementation of safety systems such as pressure relief devices, lockout/tagout procedures, and containment.
Train operations and maintenance staff in the correct and safe use of process heating and CIP/SIP systems.
Work closely with Quality Assurance, Production, EHS, and Validation teams to ensure aligned operations and hygienic conditions.
Support product changeovers, system sanitization, and cleaning verification processes.
Participate in audit preparation and act as SME (Subject Matter Expert) during regulatory or customer inspections.
Thermal Process Systems: Steam boilers, clean steam generators, water heating loops, CIP heating systems.
Sanitary Process Design: Hygienic piping, spray balls, tank cleaning systems, valves and fittings (3-A, EHEDG compliance).
Process Control: Automation and instrumentation for temperature, flow, pressure, and cleaning cycles.
Utilities Integration: Clean steam, potable/softened water, RO water, and chemical systems supporting sanitation.
Documentation & Validation: SOPs, P&IDs, CIP recipes, and validation protocols.
Bachelor’s degree in Mechanical, Chemical, or Industrial Engineering (Master’s preferred).
10+ years of experience in process engineering, utilities, or sanitation systems, with at least 5 years in a leadership role.
Expertise in sanitary system design and operations, preferably in a GMP-regulated industry.
Deep understanding of ASME BPE, 3-A standards, OSHA, and process heating principles.
Experience with CIP/SIP automation, SCADA/BMS platforms, and control loop tuning.
Strong project management, cross-functional leadership, and technical troubleshooting skills.
Certifications such as PE, PMP, or Six Sigma are desirable.