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MSD Malaysia

Associate Director, Facility & Utilities Engineering Lead

MSD Malaysia, Rahway, New Jersey, us, 07065

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* Lead the Facility & Utilities Engineering team to ensure 24/7/ 365 building support for critical GMP operations.* Manage process & facilities equipment, and utilities (clean and grey) maintenance and calibration.* Maintain redundancy through training for operation, metrology, maintenance, etc. to provide off-hours, weekends and holidays coverage.* Ensure areas of accountability are delivered in accordance with EHS regulatory and company EHS requirements.* Build robust communication channels with site support teams (utilities, etc.) and NGB operations to coordinate planned and unplanned activities, annual shutdowns to maintain robust building operations.* Manage and provide oversight to outsource service providers, such as equipment service providers, GMP area cleaning, etc.* Drive continuous improvement programme across all areas – safety, environmental management, quality compliance, equipment reliability and uptime, efficiency and operational excellence.* Manage a team, which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies.* Support facility and utilities assessment for New Product Introduction, as required.* Support Energy Management, Environmental Sustainability & Business Continuity activities through data.* Accountable for delivery of Engineering spend within approved budget.* Investigate equipment failures or area deviations to find root cause and implement effective Corrective and Preventative Actions (CAPA).* Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan.* Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed.* Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.* Prior experience of team management and monitoring performance* Possess a deep understanding of a facilities and engineering management in GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of clean utilities systems.* Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for operations.* Ability to perform technical analysis to drive continuous improvement and overall efficiency.* Culture Building: Establish a high-performance culture that promotes innovation, diversity, and inclusion within the team* Track record of working effectively with team-members of diverse skill sets and backgrounds* Excellent troubleshooting and problem-solving skills and the ability to overcome technical and organizational challenges* Delta V and MES (Manufacturing Execution System) knowledge and experience* Strong verbal and written communication skills, and attention to detail* Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to engineering.* Proven self-motivation, ability to drive improvements, and inspire others.* Demonstrated ability to work effectively as part of diverse teams.* Ability to challenge the status quo with a continuous improvement mindset.* Strong leadership ability and collaborative skills.* Strong analytical and presentation skills.* Ability to lift 25 lbs, if required.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr