Plant Engineer
Xellia

Cleveland, Ohio

Posted in Pharmaceuticals


This job has expired.

Job Info


The Plant Engineer - Utilitieswill support the Utilities Department by providing technical and strategic expertise in terms of the life cycle asset management and the associated practices to ensure maximum equipment performance and uptime. This will be accomplished by analysis, process mapping and improvements through equipment reliability, availability and maintainability. Including the application of Reliability Centered Maintenance (RCM), strategies, proactive maintenance and TPM / Lean principles and practices.

The Utilities Plant Engineer primary responsibility will be, to ensure equipment health, uptime, and reliance of the Xellia Site Utilities. Working to ensure maximum equipment uptime, support of investigations and complaints. Evaluate and authorize changes to equipment. This role will also serve as the primary point of contact for deviations, corrective and/or preventive actions (CAPAs), Preventive Maintenance and Change Controls for the equipment under his/her responsibility.

Key Responsibilities

  • The Utilities Plant Engineer will spend >50% of their time on the floor in direct support of the Utilities Department ensuring equipment uptime and providing technical oversight to both their operations customers as well as a various support groups (Quality, Validation, etc.)
  • Evaluate and Recommend Spare Parts, assist Utilities Maintenance team to identify suitable spare parts list and inventory levels in order to not adversely impact continuous operations. Responsible for technical evaluation and ensuring that suitable spares are identified and maintained for obsolete or replaced parts.
  • Responsible for ensuring Preventive Maintenance has appropriate technical detail and frequencies established.
  • Lead FMEA analysis for the assigned areas and equipment.
  • Track Equipment Down time in a routing manner and present the monthly trend to the Engineering & Maintenance Manager.
  • Evaluate Down time data and Identify Root Causes and Implement Corrective actions as required.
  • Support Maintenance Team on troubleshooting activities.
  • Evaluate and/or recommend equipment modifications to improve equipment reliability.
  • Deviation Support - Provide Technical Support on Equipment evaluations impacting equipment under their area ownership.
  • Lead or support projects related to equipment improvement and or replacement as required.
  • Continuously upgrade personal technical skill levels to assure application of best available technology and techniques for addressing maintenance and reliability issues.
  • Evaluate and recommend PdM technologies that can be used on our equipment.
  • Lead or support capital projects.
  • Write/review equipment User Requirements Specifications (URS) and Design documents.
  • Works with Operations and Maintenance to ensure corrective maintenance work or project implementation actives are efficiently scheduled
  • Monitors and insures company compliance with regulatory standards.
  • Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee 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 21CFR part 210 and 211, cGMP's, FDA, OSHA, EPA and other regulatory agencies.
  • Personnel engaged in the manufacture, 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.
  • Other related duties as assigned to meet departmental and Company

Requirements

  • Bachelor's Degree of Engineering, Mechanical, Electrical, or Chemical is preferred with a minimum of 3 years of experience in a related field
  • Certified as CRE (Certification of Reliability Engineering) or CMRP (Certified Maintenance and Reliability Professional) preferred.
  • Exhibit a continuous improvement mindset, high level attention to details and advance organizational skills. Be able to make sound decisions when faced with competing priorities.
  • Experienced in problem solving with emphasis on strong interpersonal skills necessary to interact across various functional groups.
  • Expertise in Spare Parts management, Calibration, CMMS applications such as AMMS, Maximo, etc.
  • Some familiarity with predictive tools such as; infrared thermography, vibration analysis, oil analysis, motor analysis etc.
  • Excellent verbal and written communication skills
  • Military service highly desirable

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.

Read more about Xellia Pharmaceuticals here


This job has expired.

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