15 May

Engineering Maintenance Director Jobs Vacancy in Xellia Pharmaceuticals Chicago

Position
Engineering Maintenance Director
Company
Xellia Pharmaceuticals
Location
Chicago IL
Opening
15 May, 2018 7 days ago

Xellia Pharmaceuticals Chicago urgently required following position for Engineering Maintenance Director. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Engineering Maintenance Director Jobs Vacancy in Xellia Pharmaceuticals Chicago Jobs Details:

Engineering & Maintenance Director
Corporate project management


Position Summary
Responsibilities include providing pro-active administrative and technical leadership to facility, utilities, calibration, space planning, security and related projects. Fosters innovation and executes strategies to meet site objectives, ensure reliability, and regulatory compliance including preventative and predictive maintenance programs as well as site capital (CAPEX) budget. This department has the overall responsibility for the management and supervision of all facilities, utilities, and calibration activities for the Xellia Cleveland site. This includes, but not limited to the areas of building utilities, grounds and building maintenance, as well as maintenance system improvements.
Key Responsibilities
  • Plans, organizes and directs the Maintenance and Engineering activities and programs relating to the reliability and improvement of the site, including the evaluation and purchase of new equipment, improvement and modification/renovation of existing equipment and facilities. Directs and approves maintenance activities to ensure the maintenance of Company facilities in a manner consistent with established long and short term objectives.
  • Takes ownership for, develops and/or continually improves maintenance programs (PM, Work Order System, etc.)
  • Assure compliance with all governmental, state and local regulations.
  • Administers personnel development programs within Maintenance. Conducts periodic performance reviews, trains and prepares for orderly succession of positions. Facilitates the development and continuity of effective teamwork toward achievement of site goals. Develops climate conducive to trust, open communications, mutual goal setting, and recognition.
  • Assists, plans, develop and implements Maintenance strategies required for meeting company objectives.
  • Responsible for developing, managing and implementing the Engineering and Maintenance budget.
  • Identifies and implements improvement projects to reduce manufacturing costs.
  • Assures the participation of Maintenance in the selection, testing and evaluation of new processes and equipment. Provides assistance and Maintenance expertise in the start-up and validation of systems and equipment.
  • Assists with the selection, purchase and installation of new equipment, modification of existing equipment, and the removal and disposition of obsolete equipment.
  • Directs establishment and monitors general and preventative maintenance programs developed to insure timely and efficient repair and maintenance of machinery, equipment, facilities and support systems through reporting personnel responsible for implementation of established programs. Directs responsible subordinate personnel in establishment and adherence to long-range maintenance and planning goals.
  • Maintains accurate working knowledge of governmental/regulatory requirements as related to equipment including EPA, OSHA, and the FDA. Monitors and insures company compliance with regulatory standards. Accompanies agency representative or inspector as required. Responds to infractions.
  • Responsible for developing and managing the space planning for the facility.
  • Directs the calibration program and ensures a timely completion of the program.
  • Manages the security team of the site.
  • Other related duties as assigned to meet departmental and Company objectives.
  • 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 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
  • Bachelor's Degree in Mechanical, Electrical, or Chemical Engineering, is preferred, with a minimum of 10 years of broad-based technical management, preferably in a pharmaceutical manufacturing environment. Also, a minimum of 5 years of management experience required for this position.
  • Certification of Reliability Engineering preferred.
  • Knowledge of manufacturing equipment and process of flexible containers (IV bags) preferred.
  • Expertise in Facilities, Calibration, Utilities management, Security management, and space planning experience is required.
  • Expertise in capital budget (CAPEX) preparation and control is required.
  • Demonstrated positive results in progressive positions of authority, including a record of success in a cGMP pharmaceutical manufacturing environment.

Physical Requirements of the Role
Position is exposed to plant environment. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 25 lbs. Standing, walking, bending over and repetitive use of legs are done occasionally. 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.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.



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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