Maintenance ManagerJob Description Summary: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.
Primary 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
Experience and Skills Desired:- 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
- Knowledge of Six Sigma and lean systems is a plus
- 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
