This position is responsible for providing frontline leadership to maintenance mechanics and technicians supporting an Aseptic Production Process. The supervisor 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 supervisor will provide coaching, training and guidance and ensure work is properly documented within a computerized maintenance management system.
- Support the Operations Supervisors with ensuring adherence to the production plan. .
- 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.
- Ensure that systematic problem solving happens on the shop floor where all relevant stakeholders are involved.
- Ensure that the current requirements for Environmental, Safety and Health issues are met within the production operations.
- Include relevant stakeholders in decision-making in regards to equipment, processes and other daily operations.
- 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.
- Assist in the development and writing of departmental procedures.
- Provide hands on technical advice, support and solutions pertaining to equipment issues.
- Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversees 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 21 CFR Parts 210 and 211, CGMPs, FDA, OSHA and other regulatory agencies.
- Personnel engaged in the manufacturer, 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.
Physical Requirements of the Role
Required: HS Diploma/GED and 6+ years applicable experience
Preferred: Bachelors of Science and 0-5 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.
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 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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