Associate Director, Facility & Utilities Engineering Lead

* 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
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