Principal Engineer
Xellia

Job Info

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The Principal Plant Engineer will support the Engineering and Maintenance Department by providing technical and strategic expertise in terms of the life cycle asset management and the associated practices to ensure maximum possible 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 Principal Plant Engineer primary responsibility will be to ensure equipment health for their designated area of responsibility. Working with Operations, Quality, Maintenance 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.

The Principal Plant Engineer will guidance to a group of Plant Engineers as an intermediary for Engineering Senior Manager ensuring that individual and team objectives are met while mentoring and coaching team members in key responsibilities and development. .

Key Responsibilities

• System owner of assigned area, responsible and accountable for equipment reliability.
• Cross train with other Plant Engineers to support and cover other systems/areas.
• Assist to, develop, mentoring, and train Plant Engineers.
• Assign tasks to Plant Engineers to support Site Operations
• Support during 24/7 operations and will required to cover in different shift during development runs and Media Fills to support projects.
• The Principal Plant Engineer will Engineering immediate point of contact in support of manufacturing operations 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 Maintenance/Utilities Maintenance team to identify suitable spare parts list and inventory levels 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 predictive maintenance (PdM) technologies that can be used on our equipment.
• 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 ensures 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 and themselves.
• Other related duties as assigned to meet departmental and Company needs

Requirements

• Bachelor of Science in Engineering (preferred), Mechanical, Electrical, or Chemical is preferred with a minimum of 10 years of experience in a related field
• Minimum 12 years of experience in the Pharmaceutical industry with emphasis in Bag Filling, Aseptic Filling, & Lyophilized injectable products and automated equipment.
• Technical Expert in Electromechanical systems and troubleshooting
• 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.
• Familiarity with PdMtools such as; infrared thermography, vibration analysis, oil analysis, motor analysis etc.
• Excellent verbal and written communication skills
• Military service highly desirable

Physical Requirements of the Role

Frequently sitting, talking, and fine manipulation. Occasionally standing, walking, crawling, reaching, kneeling, pushing, pulling, repetitive motions with hands, arms, and legs. Must be able to lift and carry 25 lbs or less.

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 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

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