Production Mechanic
Xellia

Cleveland, Ohio

This job has expired.


This position will maintain systems and equipment within the Aseptic production process. The mechanic is responsible for supporting the Aseptic Production Process by performing maintenance on all equipment with a high quality mindset, safely and within a defined schedule. The mechanic will perform maintenance on equipment and components related to compressed air, electromechanical, controls, electrical, mechanical, instrumentation and robotics. Additionally, the mechanic will be responsible for documenting all actions in equipment logs and a computerized maintenance management system.

This is a second shift position

Key Responsibilities

  • Perform maintenance assignments, to include routine maintenance, diagnostics, troubleshooting, repair, installation and overhaul of manufacturing / processing equipment within an Aseptic Production environment
  • Ensure that the Aseptic production equipment is maintained to an appropriate standard in line with current pharmaceutical regulatory requirements, industry standards, government regulations and requirements as well the guidelines set by Xellia
  • Provide maintenance support to all aspects of the production efforts as established in department procedures and as required by regulatory agencies in order to ensure, and maintain, safe, cGMP compliant equipment and facilities
  • Contribute as required to maintain all production equipment maintenance within the scheduled completion dates while maintaining the validated state of the production process. Perform routine preventive maintenance in an aseptic environment on production machinery and equipment including mechanical, electro-mechanical, pneumatic, robotic and other systems
  • Complete and document, per SOP's and regulatory requirements, all corrective and routine preventive maintenance as well as scheduled performance evaluations for assigned equipment
  • Utilize a Computerized Maintenance Management System (CMMS) to document and track maintenance activities
  • Ensure that all production equipment is running optimally, both in terms of output and quality and assist operations as needed in order to meet company quality and production targets
  • Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversees that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21 CFR Parts 210 and 211, CGMPs, FDA, OSHA and other regulatory agencies
  • Personnel engaged in the manufacturer, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings shall be worn as necessary to protect drug products from contamination

Requirements

  • Completed apprentice/journeyman program in a maintenance related field such as machine repairman or technical vocational certificates from an accredited tech/trade school is preferred
  • Experience in pharmaceutical maintenance with Aseptic or Injectable experience preferred
  • Ability to understand, and work with, regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies
  • Demonstrated ability to read, comprehend and interpret equipment manuals, mechanical and electrical drawings and PLC logic
  • Ability to assemble/disassemble and repair machine components (i.e., gears, bearings, shafts, chains, sprockets, pulleys, cams, etc.). Able to use precision measuring equipment (i.e., dial calipers, micrometers, etc.)
  • Ability to read, comprehend and execute Standard Operating Procedures (SOP) and instruction documents
  • Knowledge of CMMS programs and current regulatory requirements regarding Environmental Health & Safety

Physical Requirements of the Role

This is a very physical and active position with continuously sitting, standing, and walking, and repetitive hand, arms, and leg movements. Must be able to continuously lift and carry 25 lbs or less. Must be able to gown. Occasionally, crawling, climbing, reaching, crouching, kneeling, balancing, pushing and pulling. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.

Further information about Xellia can be found at: www.xellia.com

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