Clean Utilities Specialist

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 unlock the power of gene therapy to accelerate healthcare transformation.

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

We are currently seeking a Clean Utilities Specialist for our new GTIC (Gene Therapy Innovation Center). Following is an overview of the role:

Performs and documents daily rounds in accordance with GDP (GMP) and is the primary operator of all clean utilities including clean compressed air, clean gases, Water for Injection (WFI), Clean Steam, autoclaves, and parts washers.

Works in collaboration with clean utility engineer to perform daily system monitoring to drive emergent work via daily rounds, system alarm monitoring and the inclusion of conditioned-based maintenance tools and techniques as directed.

Works in collaboration with manufacturing mechanics in support of clean utilities operation in the clean suite, acts as manufacturing mechanic back up to manufacturing and maintains aseptic gowning qualified.

Performs maintenance of the clean utility systems and acts as lead, using outside service providers, as required, in support system maintenance shutdowns.

Operates the site’s waste neutralization and bio in activation skids as part of the Water for Injection System.

Responsibilities

Works with maintenance planner/scheduler, metrology, asset owners and engineering to execute work as required on all clean utilities systems harmonized with the manufacturing schedule.

Complete system maintenance execution ownership, responsible for daily delivery of clean utilities to the business.

Performs and oversees vendor and self-executed maintenance activities (PMs) and repairs to clean utility systems in concert with site EHS, Quality assurance, Site engineering and facilities management.

Collaborates with Spark maintenance teams with emphasis on supporting manufacturing suite operations.

Perform daily walk throughs and periodic inspections of Clean Utilities systems using established job aid check lists.

Utilize, manage, and schedule outside resources, entirely in the Spark CMMS (Aspire/SAP).

Utilize, manage, and schedule outside resources, as required.

Always maintains facility documentation in audit ready status.

Fosters Spark Core Values, teamwork and continuously supports Sparks continued growth and success.

Requirements

3 to 5 years’ experience operating a Water for Injection or RODI water system in a regulated environment.

Working knowledge of instrument calibration.

Working knowledge of GxP Compliance and FDA guidelines.

Proficient with technical documentation including Standard Operating Procedures, Function specifications and Piping and instrumentation Diagrams (P&IDs).

Familiarity with PLC programming.

Key Skills, Abilities, and Competencies

Ability to own a critical utility in a commercial pharmaceutical environment.

Attention to detail, effectiveness and efficiency when performing work.

Ability to prioritize and multitask effectively and work independently or in a team environment.

Ability to work independently with minimal supervision and guidance.

Good working knowledge of building, mechanical and industrial principles.

Good interpersonal and strong written/verbal communication skills.

Ability to work flexible hours as needed to manage repairs and services as required.

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $97,000 to $145,600

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