Sr. Maintenance Technician - Lyophilization

Job Summary: The Senior Maintenance Technician is accountable for driving results in a fast-paced environment 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 in a highly technical fast paced environment requiring past experience related specifically to keeping production business running. 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. On-Site Expectations: * 100% on-site position in Morrisville, NC. * 1st Shift: Monday - Friday, 7:00am - 3:30pm. Responsibilities: * Maintenance of WFI distribution, CCA, Boilers, USP and other utilities as assigned. * Performs scheduled performance maintenance on equipment and records all necessary data as required and in accordance with Company SOP's and cGMP's. * Installs and retrofits facilities equipment in accordance with Company SOP's and cGMP's. * Ensures Maintenance Management informed of all developments on a routine basis. * Performs necessary repairs to equipment and physical plant as required in a safe, clean, and efficient manner to response to maintenance work requests. * Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors. Involved in developing solutions for equipment issues. * 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. Qualifications: * 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. Associate's degree preferred. * Prior cGMP experience preferred. Knowledge, Skills, and Abilities: * Excellent knowledge of cGMP in a pharmaceutical or regulated environment required. * Excellent verbal communications and presentation skills required. * Advanced electrical troubleshooting required. * Strong knowledge of general OSHA safety requirements preferred. * 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. * 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. * Working knowledge of Lyophilization preferred. Travel Expectations: * Up to 5% travel required. Physical Demands and Work Environment: The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 80 pounds and occasionally lift and/or move over 100 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

Created: 2024-11-04