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Facilities Maintenance & Metrology Lead
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jun 27
The Facilities Maintenance & Metrology Lead will establish operational objectives and assignments to ensure effective management of maintenance and metrology programs for Spark’s growing multi-site cGMP and Scientific facilities infrastructure. This individual will be tasked with overseeing the maintenance, calibration, operation and continuous improvement of all cGMP and scientific facilities process and support equipment, utilities, and analytical equipment.
Through effective and efficient management of subordinate staff, oversight of external vendors and “hands on” workload, ensures that facilities and equipment work follows safety standards, conforms to end-user requirements/specifications, and that work orders are tracked and completed within the budgeted guidelines of time and costs.
Direct and coordinate all the activities of the maintenance and metrology staff for new (start-up) and existing equipment, utilities and facilities. Maintain compliance by monitoring performance over time and developing and maintaining key performance indicators to provide a basis for the periodic reporting of metrics and process improvement.
Designs, implements, manages and monitors the maintenance program:
Establish and maintain a program of regular inspection of facilities, equipment and systems to accumulate performance data and establish preventive maintenance schedules to maximize useful life of equipment.
Perform corrective and emergency maintenance and repairs, as required.
Manage external vendor relationships for the execution of maintenance and repair activities and ensure the ready availability of spare parts, as required.
Apply measurement science, mathematics, physics and engineering to document and maintain calibration systems, procedures and use of outside calibration services, as required.
Develop and manage budgets for areas of responsibility, including staffing requirements.
Write SOPs, change controls, deviations and investigations based upon solid understanding of regulatory and Spark requirements.
Manage Facilities Maintenance and Metrology teams to achieve business goals and objectives.
Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback. Hold everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by periodically reviewing individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
Develop team members. Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential. Understand your employee’s goals, strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning, social networks and development opportunities.
Foster Spark’s Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
Strong analytical, written/verbal communication and interpersonal skills
Ability to multi-task and work independently or in a team environment with minimal supervision
Proficiency in prioritization, organization, and time management
Bachelor’s degree in an Engineering or Science-related field is required. An advanced degree is preferred.
Must have fifteen plus (15+) years of experience managing facilities functions within the pharmaceutical/biotechnology industry.
Experience with 21CFR11 compliant calibration management software/databases.
Must have strong understanding of MEP and utility systems.
Must have direct experience in the commissioning, qualification and validation of facilities, utilities, production, laboratory and support equipment.
Experience working within established standards and industry guidelines: FDA; GAMP; ISPE; ASME, cGMP; GEP; ISO; GDP, etc.
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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