Manager, Production Maintenance

Impax Laboratories, Inc. is a technology based specialty Pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.

 

Summary:  Supervises the repairs and maintenance of manufacturing process and facility equipment which includes, but not limited to Tablet Press Machines, Tablet Coaters, Encapsulators, Drying Ovens, Glatt Fluid Bed Granulators, Mills, Boilers, Chillers, Air Compressors, Oxidizers systems, and production machines and equipment by performing the following duties.

 

Essential Duties & Responsibilities include, but not limited to the following:  Responsible for the Preventative, Routine and Predictive Maintenance Programs.Responsible for the upkeep of the Facilities and utilities.Assists maintenance staff in the troubleshooting and basic repair for both mechanical and electronic production and facility equipment.Oversight and management of the Computerized Maintenance management System.Monitoring of Building Automation System, supplying reports and alarm information.Repairs or replacement of defective parts following proper change control requirements.Provides feedback on work orders requiring improved procedures or additional corrective work.Initiates purchase order for spare parts and machines.Maintains a maintenance drawing and technical manual libraryTroubleshoot and/or repairs electrical equipment using test equipment (multi-meter, oscilloscope, megger, signal generator, etc).Follows all company and safety policies and procedures such as GMPs, Lock out / Tag out, Confined space, etc.Provides timely notification to management of any discrepancy that has a direct or indirect impact on product quality.Identifies and initiates value added opportunities for continuous improvement in existing procedures, processes or equipment. Provide superior customer service.Maintain an adequate, organized and complete spare parts inventory including all consumables.Leads in the installation of new equipment, programs and projects. Assists in the engineering design, selection, and user requirements for new equipment.Maintain training readiness and assist others in improving their equipment knowledge.

· Follows all cGMPs and ensures that product is manufactured according to procedure and current Good Manufacturing Practices.

· Follows safe working practices while performing assigned duties. Identifies reports and may recommend corrective action for any unsafe conditions to a supervisor, or department manager. Adheres to safety procedures including, but not limited to wearing product specific Personal Protective Equipment (PPE) requirements, safety glasses, lock out, confine space and other company policies and procedures.

· Other duties may be assigned.


Supervisory Responsibilities:  Duties would include, but not limited to the following:

· Ensuring the maximum performance and level of customer service is being delivered by the mechanical staff

· Assisting employees to troubleshoot equipment and systems.

· Maintaining equipment, product quality and efficiencies, and equipment rebuilds.

· Providing equipment, tools and GMP training.

· Providing accurate and timely communications, ensuring all local and national regulations are being followed, such as safety, environmental, cGMPs, etc.

· Maintaining proper spare parts and inventory control.

· Maintaining operational documentation such as PMs, corrective work orders, change control, housekeeping, etc.  This includes maintaining administrative documentation, such as training records, drawings, maintenance repair records, writing new or revising existing PMs, purchase requisitions, Investigation Reports, lessons learned memos, etc as well as providing equipment and control troubleshooting, crafts and GMP training.

 

Qualifications:

· Associate Degree (mechanical/electronics) or equivalent.  Engineering degree preferred.

· Minimum 4 years experience in the maintenance of process or packaging equipment.

· Minimum 2 + years of Pharmaceutical, Biotech, Food, Cosmetic, Beverage or relevant work experience with increasing responsibilities preferred.

· Very good supervisory skills.  Must demonstrate strong technical skills in instrumentation calibration and troubleshooting for both manufacturing and laboratory.

· At least 3 years of above average performance review and a proven record of leadership.

· Must have a strong knowledge and understanding of various types of pharmaceutical equipment found in the manufacturing/packaging area, which includes, but not limited to Tablet Presses, Drying ovens, Granulators, Coating Pans, Packaging, etc.

· Must have a strong knowledge and understanding of various types of utility equipment; such as boilers, air compressors, chillers, etc.

· Excellent command of the English language; ability to read and comprehend complex instructions, and especially to write correspondence, reports and memos. Ability to effectively present information in one-on-one and small group situations to other employees of the organization. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. 

· Must have the ability to add, subtract, multiply and divide using the metric system and to perform these operations as required for calibrations.

· Must have the ability to solve practical problems and deal with a variety of situations where only limited standardization exists, to interpret a variety of instructions furnished in written, oral, diagram, or schedule form, to apply common sense understanding to carry out complex instructions and to deal with complex situations with several variables.

· Must have a strong working knowledge and experience of Microsoft Office and a Computerized Calibration Management System.  Working knowledge of a Computerized Maintenance Management System a plus. 

· The employee must frequently lift and/or move up to 50 pounds.  

· Employee must be flexible to work overtime and/or different shifts as business needs dictate.