Job Summary

The Packaging Maintenance Mechanic is responsible for the setup, diagnosing, adjustment, and repair of all oral solid dosage, pharmaceutical packaging equipment. Maintenance Mechanics will perform routine preventative maintenance to minimize equipment downtime and ensure the product produced is of the highest quality. This role will require routine documentation pertaining to downtime, spare parts, and preventative maintenance performed. This role will also assist with equipment changeovers.

Primary Responsibilities

• Ensure proper set-up and operation of oral solid dosage packaging such as but not limited to: descrambler, desiccant feeder, induction sealer, re-torquers, labelers, and outserter.
• Perform packaging equipment preventative maintenance as required.
• Ensure proper cleaning and assemble of the packaging equipment.
• Perform changeover of packaging equipment for different products including bottle size and format changes.
• Troubleshoot and correct mechanical issues as they occur.
• Ensure proper execution of batch records and standard operating procedures.
• Operate equipment as needed to ensure continuous operation of equipment.
• Function as Lead Technician (SME) in the production areas with a strong understanding of operating all equipment to achieve Overall Equipment Effectiveness (OEE).
• Interpret and carry out detailed written or verbal instructions including work orders, blueprints, drawings and sketches related to the operation, maintenance, repair, or modification of packaging equipment control and power systems while exercising judgement and discretion in the most advantageous manner.
• Assist in the installation, modification, commissioning, and qualification/validation of equipment.
• Assist Pharmaceutical Technology with new product introductions and provide feedback of processing requirements.
• Provide technical leadership and process knowledge in the training of new operations personnel.
• Contact equipment/supply vendors as needed to resolve problems and ensure limited downtime due to mechanical issues.
• May provide support in the area of small project management in the definition of requirements for and procurement of small equipment.
• Function as subject matter expert (SME) in the production areas with a strong understanding of operating all equipment to achieve Overall Equipment Effectiveness (OEE).
• Maintain strong presence on the floor to ensure that equipment problems are resolved in a timely manner with little downtime.
• Possess knowledge of working properties of common-stock materials, metallic and non-metallic.
• Disassemble equipment for repair, maintenance, modification, and/or training; reassemble the equipment, check for proper operation.
• Ensure compliance with cGMPs, OSHA, DEA, and any other regulatory guidelines and Company policies that may apply. Identify and report quality issues.
• Perform other related assignments and duties as required and assigned.
• Perform all functions according to current Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOP
• Responsible for "Downtime", "Change Over Time", "PM's" and "Productivity" results.

Education and Experience Requirements

• High School Diploma or equivalent.
• Minimum of five years of relevant pharmaceutical industry experience preferred or equivalent combination of education, demonstrated mechanical skill.

Necessary Knowledge, Skills, and Abilities

• Demonstrated advanced or expert level of mechanical knowledge, skills, and abilities supporting oral solid dose (OSD) pharmaceuticals Packaging and/or Packaging Serialization.
• Hands on maintenance, troubleshooting, repair and upgrade to packaging production equipment.
  
• Demonstrated ability to read and interpret documents such as safety policies, operating and maintenance instructions and procedure manuals, etc.
• Demonstrated ability to perform diverse and complex assignments in support of operations.
• Capability to perform basic/complex mathematical computations of addition, subtraction, multiplication, and division. Understanding of the Metric System of Measurement.
• Advanced knowledge of the functional/process area. The work calls for advanced comprehension of the area to solve unusual as well as common work problems, to be able to advise on technical matters, and to serve as a resource on the subject for others in the organization.

Highly Preferred Skills/Qualifications:

• Certification/Associate’s/Bachelor’s degree in Manufacturing, Engineering, or Technology related fields
• Operational Excellence; Six Sigma Green Belt certified
• Advanced Computerized Manufacturing
• Controls (Programmable Logic Controls); Motors & Controls; Robotics
• Maintenance, Installation, and Repair
• Diagrams/Schematics
• Root cause analysis/problem solving tools and techniques

Supervisory Responsibilities (if Applicable)

The Packaging Maintenance Mechanic has no direct reports.

Physical and Environmental

• Occasionally, transport materials using manual, and power assisted vehicles including manually pushing and pulling drums, totes, boxes, and pallets
• Frequently push, lift and maneuver boxes and materials weighing up to 50 pounds.
• Ability to work standard schedule of 10 hours a day, Monday-Thursday and overtime as needed.

Additional Information

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.