Description

　　Core Hours:Monday - Friday 10:00 pm - 6:30 amPurpose and ScopeThe Production Maintenance Supervisor is responsible for the overallsupervision, planning, scheduling and follow-up activities of themaintenance of the production and packaging equipment and aseptic processes.Provide technical support for general manufacturing and aseptic process areas.Essential Duties & ResponsibilitiesWork in conjunction with the Maintenance Manager to direct activities toensure operational readiness of all Tolmar facilities and equipment, withinbudget and in compliance with established regulations.Manage all production maintenance systems and personnel to ensure all workorders are completed within the parameters of the plant-wide work order systemin a timely and quality manner.Hire, train, supervise, counsel and evaluate direct-report employees;conduct and submit annual performance appraisals; recommend/authorize payadjustments as appropriate.Establish training program for Production Maintenance Technicians incollaboration with Maintenance Manager.Responsible for maintaining spare parts inventory for assigned equipment,including monitoring levels, initiating requisitions, completing budgetreview, and ordering necessary materials.Assist with quality event investigations and company audits.Assist in facility layout and design for newer processes areas and expansionat other facilities.Ensure the development and adherence to all production equipment preventativemaintenance schedules.Contract with outside service providers for various facility andequipment-related maintenance needs.Provide recommendations to executive management to resolve maintenance issuesand operation improvement.Maintain process equipment and machinery and perform scheduled maintenanceoperations.Responsible for engineering support and maintaining equipment and processes toinclude the construction, modification and improvement of equipmentutilizing direct reports.Responsible for training and directing Maintenance Technician I, II and IIIstaff 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 incompliance with cGMP standards.Develop and maintain successful working relationships with both internal andexternal clients.Assist Maintenance Manager with preparation of budget for department andmonitor adherence to budgetEnsure the department's compliance to established company safety policiesand procedures. Be an advocate for safety programs.Represent the production maintenance department at company meetings asnecessary.Participate in required annual hazardous waste training. Hazardous wasteinvolvement may include but is not limited to the handling of universal wastesuch as spent fluorescent tubes, spent filters, batteries, and used oil.Responsible for daily activities and supervising staff that are universalhazardous waste generators and/or handlers. Respond to spills per CP030-0202 Chemical Spill Response.Perform other duties as assigned.Knowledge, Skills & AbilitiesWorking knowledge of current Good Manufacturing Practices (cGMP) and/orISO 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 writtencommunication skills.High mechanical aptitude; ability to analyze the mechanics of new equipmentfor the most efficient outcome.Overall technical competencies necessary to manage and direct skilledmaintenance technicians.Procedure writing and review skills.Computer skills include Word, Excel, and PM scheduling.Demonstrated ability to work efficiently under conditions of multipledeadlines and changing priorities in producti n.Ability to problem-solve a broad range of technical issues.Ability to plan and work with supporting technical resources such as internalengineers and scientists as well as contract support and external suppliersand consultants.Valid driver's license and acceptable MVR required.Core ValuesThe Production Maintenance Supervisor is expected to operate within theframework 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 ofour 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 & ExperienceBachelor's degree or equivalent combination of education and experience.Five years maintenance experience in a regulated industry, preferably in themanufacture of sterile drug products and/or medical devices.At least 2 years of supervisory experience preferred.Experience utilizing an automated PM scheduling, work order, spareparts, and calibration software package (Maximo preferred); cGMP auditmanagement preferred.Working Conditions