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GMP Facilities Lead

Date: Jul 24, 2019

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

Supports the design, planning and construction of facilities support equipment, systems, machinery, and buildings for GMP use.  Manages corrective, emergency and preventative maintenance including planning, scheduling and execution.  Directly interfaces with original equipment manufacturers as necessary.  Supports relevant scope development for facility modifications including estimates on equipment, labor, materials and other related costs. 

The cGMP Facilities Lead provides a wide range of facility management support services.  He/she manages the maintenance of building utilities, systems, and equipment associated with manufacturing and quality control laboratory operations.  

Interfaces with the building landlord and support services.  Addresses building outages and coordinates/cooperates with maintenance to minimize downtime and disruption to critical business operations.

Responsibilities

25%  Implements, manages and monitors the maintenance program while ensuring GMP compliance:

● Establish and maintain a program of regular inspection of facilities, equipment and systems to accumulate performance data.

● Establish preventive maintenance plans and schedules to maximize life of equipment and systems as well as ensure performance.

● Perform and coordinate execution of preventative, corrective and emergency maintenance and repairs, as required.

● Manage external vendor relationships, contract and service agreements for the execution of maintenance and repair activities

● Ensure the ready availability of spare parts, as required.

15% Participates in the daily activities of the engineering, metrology and maintenance staff for implementation of new (start-up) or modification of existing equipment, systems, utilities and facilities.

10% Assures compliance and reliability of maintenance program by monitoring performance data over time and maintaining key performance indicators to provide a basis for the periodic reporting of metrics and process improvement.

10% Solicit for bids, prepare cost estimates, and manage all building maintenance contracts to support ongoing business, operations and project needs. Perform facilities operating expense tracking and project accounting, tracking of invoices, report writing and work order record closeout in a timely fashion.

10% Write and support completion of SOPs, change controls, deviations and investigations based upon solid understanding of regulatory and Spark requirements.

5% Building and Facility primary support:

● Primary responder for calls related to emergency maintenance and issues for building and facility.

● Direct interface for building landlord and support services activities and communication.

● Act as Fire Warden and emergency services contact; member of the Safety committee. 

● Support the development, planning and implementation of environmental, industrial, health and safety programs with respect to building codes and requirements.

25% Coordinate and cooperate 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

● “Hands-On” problem solving.

● Ability to multi-task and work independently or in a team environment with minimal supervision.

● Strong analytical, written/verbal communication and interpersonal skills.

● Proficiency in prioritization, organization, and time management.

Requirements

● Bachelor’s degree preferred

● Minimum ten (10) years of related experience working in building maintenance including a minimum of five (5) years supervisory experience, preferably within the pharmaceutical/biotechnology industry.

● Knowledge of facilities, operations of building utilities and technical operations, including systems, manufacturing and laboratory equipment.

● Must have a clear understanding of GMP requirements related to maintenance and operations of critical utilities, process and analytical equipment.


Nearest Major Market: Philadelphia