Job Information
TOLMAR Inc. Production Maintenance Supervisor (3rd Shift) in Windsor, Colorado
Core Hours: Monday - Friday 10:00 pm - 6:30 am
Purpose and Scope The Production Maintenance Supervisor is responsible for the overall supervision, planning, scheduling and follow-up activities of the maintenance of the production and packaging equipment and aseptic processes. Provide technical support for general manufacturing and aseptic process areas.
Essential Duties & Responsibilities Work in conjunction with the Maintenance Manager to direct activities to ensure operational readiness of all Tolmar facilities and equipment, within budget and in compliance with established regulations. Manage all production maintenance systems and personnel to ensure all work orders are completed within the parameters of the plant-wide work order system in a timely and quality manner. Hire, train, supervise, counsel and evaluate direct-report employees; conduct and submit annual performance appraisals; recommend/authorize pay adjustments as appropriate. Establish training program for Production Maintenance Technicians in collaboration with Maintenance Manager. Responsible for maintaining spare parts inventory for assigned equipment, including monitoring levels, initiating requisitions, completing budget review, and ordering necessary materials. Assist with quality event investigations and company audits. Assist in facility layout and design for newer processes areas and expansion at other facilities. Ensure the development and adherence to all production equipment preventative maintenance schedules. Contract with outside service providers for various facility and equipment-related maintenance needs. Provide recommendations to executive management to resolve maintenance issues and operation improvement. Maintain process equipment and machinery and perform scheduled maintenance operations. Responsible for engineering support and maintaining equipment and processes to include the construction, modification and improvement of equipment utilizing direct reports. Responsible for training and directing Maintenance Technician I, II and III staff in production equipment operation, set-ups and repairs. Responsible for training maintenance and production employees on the use, maintenance and cleaning of equipment. Responsible for maintaining content of training records for department in compliance with cGMP standards. Develop and maintain successful working relationships with both internal and external clients. Assist Maintenance Manager with preparation of budget for department and monitor adherence to budget Ensure the department's compliance to established company safety policies and procedures. Be an advocate for safety programs. Represent the production maintenance department at company meetings as necessary. Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to the handling of universal waste such as spent fluorescent tubes, spent filters, batteries, and used oil. Responsible for daily activities and supervising staff that are universal hazardous waste generators and/or handlers. Respond to spills per CP 030-0202 Chemical Spill Response. Perform other duties as assigned.
Knowledge, Skills & Abilities Working knowledge of current Good Manufacturing Practices (cGMP) and/or ISO 9001 equipment requirements. Working knowledge of cGMP requirements. Knowledge of maintenance functions in a FDA regulated facility. Strong supervisory skills, coupled with excellent oral and written communication skills. High mechanical aptitude; ability to analyze the mechanics of new equipment for the most efficient outcome. Overall technical competencies necessary to manage and direct skilled maintenance technicians. Procedure writing and review skills. Computer skills include Word, Excel, and PM scheduling. Demonstrated ability to work efficiently under conditions of multiple deadlines and changing priorities in production. Abil ty to problem-solve a broad range of technical issues. Ability to plan and work with supporting technical resources such as internal engineers and scientists as well as contract support and external suppliers and consultants. Valid driver's license and acceptable MVR required.
Core Values The Production Maintenance Supervisor is expected to operate within the framework of Tolmar's Core Values: Consistently operate with the highest standards of ethics and compliance. Take ownership of your actions, success and setbacks. Respect each other and understand that honest collaboration is at the heart of our company success. Go the extra mile to make things happen. Be committed to all we do and the patients we serve. Embrace change with enthusiasm. Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education & Experience Bachelor's degree or equivalent combination of education and experience. Five years maintenance experience in a regulated industry, preferably in the manufacture of sterile drug products and/or medical devices. At least 2 years of supervisory experience preferred. Experience utilizing an automated PM scheduling, work order, spare