at Kelly Services in New Castle, Delaware, United States
Job title - Maintenance Technician
***POSITION SUMMARY -
Under guidance of the Lead Maintenance Technician, the primary responsibilities include performing routine and non-routine maintenance and repairs of Customer's GMP process manufacturing equipment (which includes but is not limited to tablet compression equipment, encapsulation equipment, packaging equipment, granulation equipment, drying and coating equipment, fluid bed dryers and other miscellaneous process support equipment) per approved procedures in order to maintain the equipment in their validated state and maintain critical production schedules.
***ESSENTIAL FUNCTIONS -
• Thoroughly assess any problems with the process equipment, identifies the problems, makes necessary repairs and completes all associated GMP documentation required to appropriately record the work performed in order to minimize equipment downtime.
• Participates in cross functional teams to identify assignable root causes for any product or equipment related deviations or anomalies, establish and implement necessary corrective and preventive actions needed to ensure the incident or anomaly is prevented in the future.
• Coordinates routine and non-routine maintenance within the master production schedule, work closely with manufacturing personnel to obtain information needed to assess equipment problems in a courteous professional demeanor, as well as working with other Maintenance Technicians.
• Provides feedback or suggestions for improvements to new or existing PM procedures and processes necessary to ensure reliable machine performance, to ensure spare parts and lubricants are properly identified and associated inventories maintained.
• Assist in the executing of the Preventive Maintenance schedules to ensure peak productivity and highest quality possible.
• Reviews, verifies and signs off on completed work assignments. Ensures accuracy of all paperwork completed is in compliance with Good Documentation Practices and complete in a timely manner. Documents all activities required by SOP, Policy and other work instruction.
• Notifies management if specifications cannot be met and/or quality or safety is being compromised. Communicates if any safety equipment is not functional and if any employee does not practice proper safety procedures.
• Monitors and requests new supplies, change parts and spare parts as needed. Identifies and helps maintain inventories of critical spare / change parts. Source and order replacement parts as needed, identifying change parts and orders required for non-stock items.
• Must exercise excellent technical, mechanical and control system aptitude and skills in order to accurately identify root causes for machine failures or breakdowns and repair accordingly.
• Read and understand construction and machine blue prints, including machine drawings, building construction floor plans, P&ID diagrams, electrical drawings, schematics for pneumatic, gas supply, vacuum and high pressure piping systems.
• Understand DC, AC circuits, motor control and measuring techniques.
• Computer skills to include Microsoft Office suite proficiency.
• Responsible for understanding the proper use of engineering and maintenance documentation, which is required under cGMPs. Examples include the Maintenance Work Order System, the Critical Change Request System, SOP documentation, Validation documentation, etc.
***EXPERIENCE AND QUALIFICATIONS:
o High school diploma or equivalent
o Associates degree in technical discipline (Engineering, Mechanics, etc.) preferred.
• INDUSTRY EXPERIENCE REQUIRED
o Must have strong mechanical, electrical and control systems knowledge, skills and experience in order to thoroughly assess any problems with the process equipment, identify the problems, make the necessary repairs and complete all associate GMP documentation required.
o LEVEL II – Two (2) to five (5) years related experience working in the solid dosage pharmaceutical industry related equipment. Experience from other industries considered.
o Advanced technical mechanical skills experience with solid dosage related systems and equipment. Strong knowledge of cGMPs.
o Knowledge of OSHA and MOSHA regulations.
• SPECIALIZED CERTIFICATIONS/ LICENSE/TRAINING
o Certifications or license in specialized related mechanical training a plus.
***KNOWLEDGE, SKILLS AND ABILITIES:
• COMMUNICATION SKILLS
o Demonstrate written skills and abilities to ensure compliance with “Good Documentation Practices”. Must have the ability to write procedures, investigations, etc. to support the Maintenance and Manufacturing departments.
o Verbal Skills: Must be skillful in approaching individuals or groups in order to give clear instructions, obtain desired results, gain compliance with established policies and procedures, and establish rapport with team (inter – intra departmentally). Must be able to communicate information that may range from easily understood to highly technical.
• COMPUTER SKILLS
o Intermediate level of skills and knowledge of Microsoft Office applications including Word, Excel and Outlook.
o Ability to generate reports and access information on the company's network server files.
o Ability to navigate the work order system, generate purchase orders and scheduling work for others.
o SAP or other similar MRP system knowledge and experience preferred.
• REASONING ABILITY
o Must be able to apply problem solving skills and methodologies including but not limited to root cause analysis, identify alternative solutions, and implement best strategy to resolve problem.
o Demonstrate strong technical/mechanical skills associated with solid dosage related systems and equipment and strong knowledge of cGMPs.
o Demonstrated ability to read and understand PLC (programmable logic controller) control logic, as well as other configurable controllers such as VFD's, relay logic, etc.
o Must be self-motivated working with minimum supervisions.
o Must be a self-starter, persuasive and flexible in actions willing to assume and demonstrate the lead role to subordinates.
o The work requires considerable and strenuous physical exertion with frequent climbing of ladders, working with minute hardware, working in a lying position, and with arms extended overhead.
o Must be physically capable of using a respirator and other personal protection equipment and devices.
o Requires proper and safe operation of any powered and un-powered hand tools, machine shop equipment and other equipment require in the normal course of duties.
o Must have color vision in both eyes and capable of reading fine print.
o Ability to lift and/or move up to 50 pounds and occasionally 75 pounds.
o Exposure to dust, odors, moderate noise and fumes.
o Must wear Personal Protection Equipment requires in designated areas.
What can we offer?
A culture that values opportunity for professional growth and development
Comprehensive medical, dental, vision, and disability benefits programs
Group retirement savings program
Health and wellness programs
Holiday and Vacation paid time off
RELOCATION ASSISTANCE - if qualified.