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Overview We are seeking a strategic and technically adept Engineer of Pharmaceutical Clean Utilities to lead the design, deployment, and maintenance of the clean utilities Purified and WFI systems, pure steam, clean compressed air, nitrogen gas system, clean room HVAC system in a GMP-compliant pharmaceutical manufacturing facility. This individual will be responsible for the full lifecycle, encompassing system integration, validation, and ensuring operational compliance. The successful candidate will lead cross-functional efforts to implement designs and planning solutions that drive quality, compliance, efficiency, and scalability across manufacturing operations.

Responsibilities System Ownership :

Manage WFI, purified water (PW), pure steam (PS), clean compressed air, clean nitrogen generation and distribution loops and cleanroom HVAC system in compliance with local regulation and cGMP requirements, as per USP Water for Pharmaceutical Purposes, ISPE Baseline Guide Vol. 4 (Water and Steam Systems), ISO 8573-1 for compressed air/gas purity classification and

ISO14644

cleanrooms and associated controlled environments, EC Annex 1 manufacture of sterile medicinal products.

Project Execution :

Lead design, budgeting, procurement, and construction phases for facility expansions or equipment upgrades.

Commissioning & Validation :

Execute and approve Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and

IQ/OQ/PQ

protocols, as per cGMP standards, as per ASTM E2500 and ISPE Baseline Guide Vol. 5 (Commissioning & Qualification). Establish a risk-based, science-based approach rather than the traditional

DQ/IQ/OQ/PQ

model.

Compliance & Quality :

Maintain hygienic design rules (ASME

BPE, EHEDG

) and align with FDA and EMA guidelines for both non-sterile and sterile clean utility systems. Establish planning and execution to meet at minimum requirements established in EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) in coordination with the Contamination Control Strategy (CCS) implementation for critical utilities (WFI, pure steam, clean compressed air, and nitrogen). Leads investigates for clean utility system and issue deviations and root causes as per Site procedures.

Reliability & Maintenance :

Monitor performance data, optimize operational uptime, and support predictive maintenance routines.

Qualifications Required Qualifications:

Bachelor's or Master's degree in Mechanical, Chemical, or Process Engineering. 3 to 6+ years of engineering or maintenance experience within a cGMP-regulated pharmaceutical or biotech setting. Strong background in thermal or membrane WFI technologies, P&ID reviews, root cause analysis (RCA), and automation logic. Demonstrated expertise in managing validated systems and supporting regulatory audits. Proficient in

PLC, SCADA, BMS/EMS, MES

systems, and network architecture.

Knowledge / Skills

/

Abilities:

Strong organizational, analytical, and technical problem-solving skills. Excellent verbal and written communication. Hands-on leadership style with experience in team development. Demonstrated ability to work cross-functionally and lead strategic initiatives. Proficient in c

GMP, GAMP5, 21 CFR

Part 11, and data integrity principles.

Physical Requirements:

Must be able to work in office and GMP production environments. Able to wear PPE and access mechanical spaces when necessary. May require lifting up to 25 lbs and occasional off-shift work for system commissioning or troubleshooting. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.