2nd Shift Lyo/Utility Supervisor
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København
Maintenance
Position Summary
This position will have the overall responsibility for the supervision of the maintenance and operation activities of site Utilities such as: Plant Steam, HVAC System, Chill Water, Pre-Treatment Water Systems, WFI System, Clean Steam, etc. and Freeze Dryer units. This includes, but not limited to the areas of building utilities, manufacturing technical support, supporting construction efforts, and general building maintenance. Responsible for maintaining facilities and equipment to ensure regulatory compliance for Aseptic Production Areas, Controlled Classified work areas and technical spaces.
Individual will lead a team responsible for the maintenance and repair of the equipment supporting the Utilities and Lyophilization units. Ensures work is performed in a safe and environmentally sound manner, documenting job completion, and documenting history of work in the computer system.
Key Responsibilities
- Ensure execution of preventative maintenance (PM) activities for the equipment and systems under his/her responsibility as per schedule.
- Ensures execution of calibration activities for the equipment and system under his/her responsibility as per schedule.
- Review PM and Calibration Work Orders (WO) documentation after execution and close them on the CMMS system.
- Evaluate, Coordinate and Approve Non- Routine Maintenance repair for the equipment and system under his/her responsibility as per approved SOP’s.
- Interacting with other departments to ensure the proper functioning of all systems in a facility.
- Ensure that the current requirements for Environmental, Safety and Health issues are met within the Utilities and Freeze Driers operations.
- Generate purchase requisitions and other documents for the procurement of spare and replacement parts.
- Provide guidance on routine and complex maintenance procedures to less experienced personnel.
- Assist with equipment installation, repair, cleaning, and other maintenance activities.
- Assist on the testing and troubleshooting of electrical and mechanical equipment. Ensure that systematic problem solving happens on the shop floor where all relevant stakeholders are involved.
- Support Facilities and Engineering personnel in completion of equipment and process qualification and validation activities.
- Assist in the development and writing of departmental procedures.
- Develop, revise and approve of PM instructions for equipment and systems under his/her responsibility.
- Develop staff competencies through coaching, training and feedback.
- Ensure employees are trained and current in all applicable procedures and cGMP’s.
- Knowledgeable of regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
- Include relevant stakeholders in decision-making in regard to equipment, processes and other daily operations.
- 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 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
- Degree vocational school or college with a focus in Mechanical or Electrical fields required
- HS Diploma/GED and 6+ years applicable experience required
- Strong aptitude / skills in mechanical, electrical and equipment control systems.
- Bachelor of Science and 0-5 years applicable experience is highly preferred
- Advanced computer skills proficiency
- Prior experience with lyophilization, clean and black utilities, processing facilities highly preferred.
- Pharmaceutical experience within an Aseptic or Injectable experience preferred.
- Demonstrated positive results in progressive positions of authority, including a record of success in a cGMP sterile manufacturing environment.
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
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.8.2020, men kan have været deaktiveret og genaktiveret igen.
- Øvrige
- København
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