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Facilities Leader

Date: Nov 18, 2018

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

Summary

 

The Facilities Leader will establish operational objectives and assignments to ensure effective management of the engineering, metrology and maintenance programs for Spark’s growing multi-site cGMP and Scientific facilities infrastructure.  This individual will be tasked with overseeing the maintenance, 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.

Responsibilities

20%         

  • Direct and coordinate all the daily activities of the engineering, metrology and maintenance 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.

15%         

  • Design, implement and manage the capital equipment program, including: reviewing for compliance with engineering principles, company standards and related specifications; coordinating/prioritizing activities, scheduling and resolving engineering concerns; supervise internal resources and/or outside contractors who are assigned projects; and develop/maintain the associated engineering records.

15%         

  • Design, implement, manage 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.

15%         

  • Apply measurement science, mathematics, physics and engineering to document and maintain calibration systems, procedures and use of outside calibration services, as required.

10%         

  • Develop and manage budgets for areas of responsibility, including staffing requirements. 

10%         

  • Write SOPs, change controls, deviations and investigations based upon solid understanding of regulatory and Spark requirements.

15%         

  • Manage Facilities, Engineering, Metrology and Maintenance 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.

Qualifications

  • 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

Requirements

  • 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/maintenance 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.

Competencies


Nearest Major Market: Philadelphia

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