Xellia
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Process Support Lead - 2nd Shift
Location:
Cleveland, OH
Description:
This position is responsible for providing frontline technical leadership to maintenance mechanics and technicians supporting the aseptic production process. The Process Support Lead will work collaboratively with the operations, quality and engineering functions to ensure continuous support of the aseptic production process. This position will maintain active engagement on the plant floor and within the daily manufacturing routines. The lead will assist and support the Process Support Supervisor through technical coaching, training and guidance and ensure work is properly documented within a computerized maintenance management system. Hours: Wednesday - Satruday, 6:00pm - 4:30amLocation - Onsite, Bedford OhioKey Responsibilities * Ensure training compliance for assigned curriculum prior to performing any work task. * Lead as required in the on-the-job training of Process Support personnel. * Serve as supervisory technical liaison for assigned shift. * Assist in the scheduling of shift/daily/weekly tasks in conjunction with area supervisor. * Perform troubleshooting and maintenance of key manufacturing equipment: including (but not limited to) autoclave, parts washers, filler, capper, CIP/SIP skid, etc. * Ensure department tasks performed are documented as per established Good Documentation Practices, and review of executed documentation (work orders, logbooks, etc.) in a timely fashion * Assist in the execution of equipment/process qualification, validation, and protocols. * Lead and facilitate the development and creation of departmental procedures to include but not limited to SOPs, OJTs, PM's, Cal's and work instruction documents. * Drive continuous improvement through leading and facilitating the team using operational excellence tools and processes such as Lean, 5S, etc. * Participate in investigations and execute appropriate approved corrective / preventative actions for Aseptic Core related processes. * Support the Operations Supervisors with ensuring adherence to the production plan. * Develop staff competencies through coaching, training and feedback. * Ensure on time completion of all planned and corrective maintenance work orders for all maintenance and instrumentation systems, ex. preventive maintenance and calibrations as well as unplanned work. * 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 Parts 210 and 211, cGMPs, FDA, OSHA 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.Requirements (list both minimum and preferred requirements)Minimum Requirements: * Required: HS Diploma/GED and 3+ years applicable regulated industry experience * Preferred: Bachelor of Science and 3-5 years applicable experience; Military service highly desirable * Advanced computer skills proficiency * Pharmaceutical experience within an Aseptic or Injectable experience preferred. * Strong aptitude / skills in mechanical, electrical and machine control.Physical Requirements of the Role (list physical requirements, required PPE, etc) * This is an active position with continuously sitting, standing, and walking, and repetitive hand, arms, and leg movements. Must be able to 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 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 is a global leader in providing critical care therapies and anti-infective treatments against serious and often life-threatening infections; ranging from active pharmaceutical ingredients (APIs) to drug products (FDFs) and from generics to specialty pharmaceuticals. Customers depend on us for reliable supply and consistent quality and to exemplify responsible manufacturing, production and research and development which promote long-term sustainability. Xellia is committed to conducting business responsibly, and we continuously strive to reduce our impact on the environment in our value chain and to develop and maintain ethical supplier relationships.Headquartered in Copenhagen, Denmark, and owned by Novo Holdings A/S, Xellia Pharmaceuticals has more than 1800 employees globally. Xellia has state-of-the-art manufacturing sites in the U.S., China, Denmark and Hungary, R&D sites in Norway and Croatia and commercial operations across Europe, Asia, the Middle East and North America. As a truly international company, we benefit from a diverse and multicultural workforce. At Xellia, we believe in the freedom to be yourself and bringing your whole identity to work.Xellia Pharmaceuticals' strong market position is built on 120 years of pharmaceutical industry experience. With the patient in focus, Xellia is building a pipeline of value-added critical care therapies which aim to enhance patient care by providing convenience and ease of use for healthcare professionals.Further information about Xellia can be found at: www.xellia.comConnect with us on LinkedIn
Company:
Xellia
Posted:
March 22 on Broadbean
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More About this Listing: Process Support Lead - 2nd Shift
Process Support Lead - 2nd Shift is a Science & Pharmaceutical Process Support Lead - nd Job at Xellia located in Cleveland OH. Find other listings like Process Support Lead - 2nd Shift by searching Oodle for Science & Pharmaceutical Process Support Lead - nd Jobs.
Process Support Lead - 2nd Shift is a Science & Pharmaceutical Process Support Lead - nd Job at Xellia located in Cleveland OH. Find other listings like Process Support Lead - 2nd Shift by searching Oodle for Science & Pharmaceutical Process Support Lead - nd Jobs.