Clean Utilities Lead Engineer – Pharmaceutical Manufacturing
Are you passionate about delivering robust clean utility systems in high-stakes environments? We are seeking an experienced Clean Utilities Lead Engineer to oversee the design, delivery, and operational qualification of critical clean utility systems for world-class pharmaceutical manufacturing facilities.
Key Responsibilities
Lead all clean utility engineering activities across the project lifecycle, from design through commissioning and qualification.
Oversee and coordinate the delivery of process-critical utilities such as purified water (PW), water for injection (WFI), clean steam, process air, and process gases.
Collaborate closely with design teams, construction partners, and commissioning & qualification teams to ensure system requirements and regulatory compliance.
Review and approve technical documentation, drawings, specifications, and change controls related to clean utility systems.
Lead troubleshooting and resolution of complex technical issues, serving as the primary subject matter expert on clean utilities.
Ensure seamless integration of clean utility systems into facility processes, supporting both project and operational objectives.
Establish and monitor quality and performance standards; drive compliance with cGMP, FDA, EMA, and other relevant pharmaceutical regulations.
Participate in FATs, SATs, and system walkdowns to verify system installation and readiness for commissioning.
Mentor, coach, and support junior engineers and project team members.
Experience
Bachelor’s degree in Chemical, Mechanical, Process Engineering, or related discipline.
Minimum 8 years’ experience in design, construction, commissioning, and qualification of clean utility systems within the pharmaceutical or biopharmaceutical sector.
Proven expertise with purified water, WFI, clean steam, process air, and related utility systems.
Familiarity with relevant industry standards (e.g., ISPE Baseline Guides, FDA, EMA, cGMP).
Technical Skills
Strong competency in clean utility system design, process integration, and technical problem-solving.
Skilled in reviewing and approving P&IDs, equipment specifications, and technical documentation.
Experience with validation and qualification protocols (IQ/OQ/PQ) for utility systems.
Proficiency in root cause analysis, risk assessments, and commissioning methodologies.
Soft Skills & Behaviours
Strong leadership and team collaboration abilities.
Excellent communication skills—capable of interfacing with cross-functional teams and external partners.
High attention to detail and a proactive, solution-oriented approach.
Looking to shape the future of pharmaceutical manufacturing? Apply today or connect for a conversation on this pivotal role!
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