Sr. Pharmaceutical Maintenance Technician

Alcami CorporationWilmington, NC
Onsite

About The Position

The Sr. Maintenance Technician is accountable for driving results by directly supporting a wide range of service disciplines covering HVAC systems, black and clean utilities, electrical troubleshooting, mechanical equipment repair and general maintenance in an FDA registered pharmaceutical processing environment. The Sr. Maintenance Technician operates as a key team member in a highly technical schedule-based environment requiring experience related specifically to keeping production at a ready state. The Sr. Maintenance Technician applies critical thinking and considers all business impact aspects before taking job-related actions that could cause unwanted consequences such as loss of revenue, unsafe events, and other risks. The Sr. Maintenance Technician is able to apply independent judgment and perform in a small company environment, where rapid changes occur constantly.

Requirements

  • High School Diploma or equivalent with 6+ years of experience working in a regulated environment (FDA, NRC or similar performing repairs on production and/or utility equipment.
  • Strong attention to detail, problem-solving skills, and clear communication
  • Ability to troubleshoot mechanical, electrical, instrumentation, pneumatic, and utility system issues independently.
  • Knowledge of industrial safety practices and lockout and tagout procedures.
  • Strong understanding of Standard Operating Procedures required.
  • Ability to read P&ID’s and electrical schematics required.
  • Working knowledge of Microsoft Office (Word, Excel, PowerPoint) required.

Nice To Haves

  • Associate’s Degree preferred.
  • Prior pharma cGMP experience in a pharmaceutical manufacturing environment is preferred.
  • Electrical license /Journeyman’s card preferred.
  • Excellent knowledge of cGMP in a pharmaceutical or regulated environment preferred.
  • Knowledge of pharmaceutical solid dose process equipment and packaging equipment preferred.
  • Strong knowledge of general OSHA safety requirements preferred.
  • Working knowledge of Control Systems, PLCs & HMIs preferred.
  • Working knowledge of Computerized Maintenance Management Systems to schedule and document work performed preferred.
  • Working knowledge of JCI Metasys Building Management System preferred.
  • Working knowledge of machinists’ equipment such as mills and lathes preferred.

Responsibilities

  • Maintenance of Air Handlers, Chillers, Boilers, USP water systems and other utilities as assigned.
  • Performs scheduled preventive maintenance on equipment such as mixers, blenders, tablet presses, encapsulation machines, packaging equipment etc. and records all necessary data as required and in accordance with Company SOP’s and cGMP’s to maximize equipment reliability and uptime.
  • Installs and retrofits facilities equipment in accordance with Company SOP’s and cGMP’s.
  • Support startup, shutdown, commissioning, and qualification activities for critical facility systems.
  • Performs necessary repairs to equipment and physical plant as required in a safe, clean, and efficient manner in response to maintenance work requests.
  • Follows all Lock-Out/ Tag-Out procedures in accordance with Company SOP’s.
  • Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors. Involved in developing solutions for equipment issues.
  • Takes lead on tasks (performing and delegating) and makes critical contribution to the performance of the team.
  • Ensures Maintenance Management is informed of all developments on a routine basis.
  • Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner. Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).
  • Maintains an organized and clean workspace at all times.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • Is on call periodically to monitor and respond to facility and manufacturing equipment repairs and issues.
  • Other duties as assigned.
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