Maintenance Manager

Krystal Biotech•Moon Township, PA

26d

About The Position

Krystal Biotech, Inc is seeking a highly motivated Maintenance Manager to provide technical and administrative leadership at our state-of-the-art GMP facility in Moon Township, PA. This is a hands-on role that involves direct contributions with troubleshooting as well as oversight of maintenance programs, facility optimization and consistent reliability.

Requirements

6+ years of meaningful work experience in operations/manufacturing environment
3+ years of experience within highly regulated environments (i.e. cGMP, OSHA, EPA)
Experience working with GMP systems, and in-depth technical knowledge of GMP instrumentation, highly preferred
Demonstrated leadership attributes as an individual contributor (e.g., leadership of initiatives or participation on network level or continuous improvement teams)
Strong background in process improvement methodologies
Demonstrate a strong background in GMP Maintenance combined with excellent leadership and communication skills (written and verbal)
Good interpersonal, communication and problem-solving skills
Must be knowledgeable of the regulatory and GMP requirements for process equipment, instrumentation and calibration
Ability to make informed and timely decisions that consider the facts, goals, constraints, and associated risks
A team player with a can-do, proactive attitude with a passion for continuous improvement

Nice To Haves

Knowledge of Six Sigma and lean systems is a plus

Responsibilities

Leverage knowledge of GMP facilities and engineering processes, mechanical and utility systems and instrumentation to develop capabilities in diagnosis and troubleshooting of issues
Triage and resolve issues related to maintenance process non-conformances
Lead lifecycle assessments and provide recommendations for replacements and/or upgrades as needed to ensure consistent reliability
Maintain awareness of industry and regulatory trends for calibration, instrumentation and maintenance
Provide input for responses to regulatory inspections or internal audits relating to instrument calibrations or maintenance programs
Perform daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a cGMP environment with minimal supervision
Ensure safe and efficient hands-on maintenance of all manufacturing equipment and related support equipment with strict adherence to SOP's, cGMP's, and quality standards
Identify any off-nominal conditions with mechanical equipment and mechanical troubleshooting of manufacturing/utility equipment in a clean room environment
Execute daily Work Orders (WOs) and Preventative Maintenance (PM) items, and coordinate associated documentation and workflow
Act as a subject matter expert for the Facilities and Maintenance group in relevant equipment and system root cause investigations and fill the role of lead investigator where required
Ensure a safe work environment is maintained through adherence to safety guidelines and policies
Provide on-call support during operation, project and shutdown activities, as required