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Bridgewater Township, New Jersey, United States
Onsite
Position Summary
We are seeking an innovative and highly motivated Director, Global Field Service Engineering who will contribute significantly to the success of factory support, field service support, instrument installation, service maintenance, repair, and reliability enhancement of Cellares proprietary equipment in a GMP environment.
The primary focus of this position will be to lead global installation, preventative maintenance, repairs, calibration, retrofits, troubleshooting, production support, and improvement of the reliability of GMP Cellares Cell Shuttle, Bioprocessing System, Sterile Liquid Transfer System, and Cell Q equipment. This is a hands-on position at our Bridgewater, New Jersey facility.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Define and run the global service strategy and operating model
Own service budget, headcount planning, hiring, and management, and resource allocation
Oversee a global team of field service engineering and factory service engineering ensuring effective installation, maintenance, upgrades, retrofits, repair, and production support of complex instrumentation systems
Oversee a team of instrument manufacturing engineering in Cellares’ South San Francisco headquarters location, to drive improvements in the reliability of Cellares’ GMP instruments globally
Drive continuous improvement in field service, factory service, and instrument manufacturing engineering processes, leveraging data analytics to enhance response times and improve reliability of instruments
Collaborate with R&D and quality assurance teams to support installations and document the installation process
Ensure all activities adhere to GMP regulations and other relevant industry guidelines
Partner with quality, regulatory, engineering, and operations teams to address non-conformances and implement corrective actions
Create, monitor, and report on key performance indicators (KPIs) for field service and manufacturing engineering, ensuring alignment with business objectives
Set OKRs and KPIs for installation and reliability of Cellares instruments
Align service and manufacturing engineering strategies with business goals
Foster a culture of innovation, teamwork, and continuous improvement within the field service and manufacturing engineering teams
Develop and manage budgets for field service and manufacturing engineering operations, optimizing resource allocation
Develop, manage, and implement training plans for global field service, factory service, and instrument manufacturing engineering operations at all sites as Cellares builds out its global footprint
Oversee Change Requests for instrumentation in Cellares’ eQMS
Lead monthly equipment reliability meeting to identify most impactful issues to be prioritized for corrective actions
Improve service processes, response time, and customer satisfaction through standard work and continuous improvement
Drive parts/spares planning, tools, training, and knowledge management
Bachelor’s degree in engineering (mechanical, electrical, biomedical, or related field); advanced degree (MBA, MS, or PhD) preferred
10+ years of experience in field service, manufacturing engineering, or operations, with at least 5 years in a leadership role
Proven experience in GMP-regulated industries (pharmaceuticals, biotechnology, or medical devices) and familiarity with FDA, ISO, etc. standards
Strong technical knowledge of complex instrumentation systems and their application in GMP manufacturing environments
Demonstrated ability to lead global teams and manage cross-functional projects in a fast-paced, regulated environment
Excellent problem-solving, communication, and interpersonal skills
Experience with process automation, lean manufacturing, and continuous improvement methodologies (e.g., Six Sigma, Kaizen)
Ability to travel globally as needed (up to 40%)
Attendance in the plant site is considered an essential function
Detail-oriented with a commitment to maintaining high-quality standards
Excellent verbal, written, organizational, presentation and interpersonal skills
Self-awareness, integrity, authenticity, and a growth mindset