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Merck · 1 day ago

Associate Director, Facility & Utilities Engineering Lead

Rahway, NJ

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$140K/yr - $220K/yr

6+ years exp

Merck is a leading company in the biopharmaceutical sector, focused on developing drug manufacturing processes for biologics. The Facility & Utilities Engineering Lead will oversee the engineering team to ensure continuous support for GMP operations and manage facility and utilities maintenance while driving continuous improvement initiatives.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

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

Qualification

GMP ComplianceFacilities ManagementProcess OptimizationTeam ManagementDelta VManufacturing ProcessesQuality SystemsEngineering ManagementAnalytical SkillsLeadershipProblem-SolvingCommunication Skills

Required

Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 8 years relevant experience, or a Master's degree with minimum 6 years of relevant experience

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