Operating Engineer, Expert Technician

6084-Janssen Research & Development Legal Entity•Malvern, PA
•Onsite

About The Position

The Operating Engineer, Expert Technician is an onsite, hands-on, hourly wage (non-exempt) technician role on the Maintenance Team within the Site Engineering asset-management team. The team supports clinical labs, GxP warehouse operations, cell banking, and other GxP labs in Springhouse and Malvern, Pennsylvania. Maintenance is responsible for the reliability of manufacturing assets and utilities through preventive, corrective, and calibration work orders, as well as parts storeroom management. The role ensures compliant, accurate, and timely preventive, corrective, and emergency maintenance, and provides project support for clinical manufacturing, R&D laboratory operations, utilities, and facilities equipment. Work must be performed safely and cost-effectively in compliance with company policies, EHS guidelines, and Good Manufacturing Practices. The technician operates and maintains utility plant systems and equipment, troubleshoots failures, responds to alarms, and serves as a first responder to off-shift manufacturing and electrical systems problems. The role also provides technical leadership and training, coordinates technicians’ and contractors’ daily work without direct-report oversight, supports maintenance administration and quality activities, and represents Utilities in capital and maintenance projects. The position works with multidisciplinary teams and stakeholders to improve reliability, uptime, spare-parts use, and compliance.

Requirements

  • At least 10 years of hands-on maintenance technician experience as a subject-matter expert on multiple utility systems.
  • At least 5 years of experience with pharmaceutical or biotech manufacturing utility systems.
  • Solid experience with GxPs, FDA regulations, and SAP.
  • Proven ability to train others on equipment and processes.
  • Ability to lead and coordinate projects and the daily activities of a team of technicians.
  • Ability to read and interpret P&IDs, electrical schematics, SOPs, operating and maintenance instructions, and procedure manuals.
  • Influencing, partnering, collaboration, and analytical skills.
  • Excellent oral and written presentation skills and demonstrated ability to work across organizational boundaries.
  • Working knowledge of equipment including PLC control systems and HMIs.

Nice To Haves

  • Excellent verbal and written communication skills, including the ability to communicate effectively with internal and external customers.
  • Advanced knowledge of computerized maintenance management systems (CMMS), with SAP preferred.
  • Experience creating maintenance plans, SOPs, and spare parts strategies, and knowledge of related best practices.
  • Preferred skills listed: Agile Manufacturing, Assembly Operations, Capability Development, Consulting, Data Savvy, Execution Focus, Good Manufacturing Practices (GMP), Manufacturing Processes, Manufacturing Science and Technology (MSAT), Organizing, Plant Operations, Predictive Analytics, Predictive Maintenance, Problem Solving, Process Oriented, Repair Management, Safety-Oriented, and Technologically Savvy.

Responsibilities

  • Complete preventive, corrective, emergency maintenance, and project support for clinical manufacturing, R&D laboratory operations, utility, and facility equipment.
  • Perform work safely and cost-effectively in compliance with company policies, EHS guidelines, and GMP requirements.
  • Operate and maintain utility plant equipment and systems, including boilers, chillers, reverse osmosis, WFI stills, air compressors, air handling units, refrigeration, waste neutralization, and Clean-In-Place systems.
  • Handle certain chemicals as needed and respond to off-shift manufacturing and electrical systems problems.
  • Investigate, troubleshoot, and diagnose failures involving equipment, instruments, and instrumentation systems.
  • Interpret and respond to alarms as needed.
  • Perform supervisor administrative duties in the team leader’s absence, excluding direct-report oversight and Workday and ADP functions.
  • Serve as a utilities equipment and process subject-matter expert; train other Operating Engineers and cross-train I&E and mechanical technicians.
  • Ensure new hires are onboarded efficiently and have a training program.
  • Provide input and feedback to work planning and scheduling, and support schedule attainment and resource utilization.
  • Coordinate daily work of technicians and contractors in assigned areas by executing the daily schedule and responding to emergency or urgent work orders, without direct-report oversight.
  • Improve the engagement and performance of assigned individuals through leadership and communication.
  • Serve as a key delegate of the Utilities Maintenance Team Leader.
  • Support QA releases of systems and gases as needed; perform routine alarm reviews and assist with SAP notification processing as needed.
  • Participate in preventive maintenance plan development and optimization.
  • Assist with ePTW approvals for the area owner as requested and lead the TruVault periodic review process as needed.
  • Represent Maintenance at the daily reliability meeting, communicating issues and coordinating work as needed.
  • Support project teams in creating or revising SOPs, work instructions, and SAP master data.
  • Work with engineers, master data analysts, parts storeroom staff, equipment owners, process specialists, project managers, and outside vendors to create maintenance master data in the CMMS.
  • Participate in capital and maintenance projects as the Utilities systems subject-matter expert.
  • Work with project teams, OEMs, maintenance technicians, automation engineers, lab operations, QA, and QC to identify new master data and changes to existing master data.
  • Identify opportunities to improve reliability and uptime, reduce spare parts consumption, and reduce compliance risks.
  • Work with multidisciplinary teams of OEM vendors and service providers, operations, maintenance, engineering, quality, and validation.
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