Process Support Mechanic - 2nd Shift
Xellia

Cleveland, Ohio

Posted in Pharmaceuticals


This job has expired.

Job Info


This position will maintain systems and equipment within the Aseptic Production Process. The mechanic is responsible for providing maintenance support during routine operations and completing preventive maintenance, troubleshooting and repairs. The mechanic will perform maintenance on equipment and systems such as utilities, controls, electrical, mechanical, instrumentation and robotics. The mechanic will be responsible for proper documentation in equipment logbooks and a computerized maintenance management system.

Key Responsibilities

  • Perform maintenance assignments, to include routine maintenance, diagnostics, troubleshooting, repair, installation and overhaul of manufacturing / processing equipment within an Aseptic Production environment.
  • Support routine operations by providing technical guidance and oversight on the plant floor during operations.
  • 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.
  • Perform routine and non-routine maintenance in an aseptic environment on production equipment and systems.
  • Contribute as required to maintain all production equipment maintenance within the scheduled completion dates while maintaining the validated state of the equipment and process.
  • Utilize a Computerized Maintenance Management System (CMMS) to document and track maintenance activities.
  • Complete and document, per SOP's and regulatory requirements, all corrective and routine preventive maintenance as well as scheduled performance evaluations for assigned equipment.
  • 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

  • Required: HS Diploma/GED and 3+ years applicable experience
  • 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.
  • 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. 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 affect the safety or quality of a drug product 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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This job has expired.

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