Tooling and Equipment Coordinator

Posted by boblarson on

Tooling and Equipment Coordinator

Essential Job Function:

The Tooling and Equipment Coordinator must be able to carry out all Tool Room and support equipment duties as required. Must have the skills to perform the setup, troubleshooting and maintenance of process support equipment. This includes efficiency improvements and advance preparation techniques. Must undergo both internal and external training to be at the forefront of skills and techniques to continually increase the knowledge base associated with advance preparation techniques and new Operating Procedures.

The Tooling and Equipment Coordinator must be able to communicate in written and verbal English. Must have the ability to perform mathematics (addition, subtraction and multiplication). Must be capable of lifting material/equipment up to 60 lbs or manipulating material up to 200 lbs. Will be required to read, comprehend and comply with cGMP regulations in conjunction with Standard Operating Procedures.

The Tooling and Equipment Coordinator must be trained by a certified tooling manufacturing company or equivalent.

 General Information:

Responsibilities to include, but not limited to:

 General

  1. Excellent organizational skills coupled with strong mechanical ability and willingness to be a “hands-on” employee.
  2. Perform, assist, oversee and coach tasks performed by Entry-Level Operators as requested by the Manager of Operations.
  3. Perform all duties supporting and surrounding manufacturing independently; with minimal or no supervision required.
  4. Understand processing instructions and process flows of products to be able to anticipate upcoming equipment needs that may be required.
  5. Full knowledge of various equipment including tablet presses, encapsulation equipment, fluid beds and associated support equipment.
  6. Immediately communicate any deviations or problem issues to the Management.
  7. Cooperate with fellow employees and Supervisors especially with respect to working together safely and in accordance with cGMP to get the required work done.
  8. Responsible for troubleshooting and making minor repairs to keep support equipment operating within specs.  Contact Supervisor and Facilities for major support equipment repairs.
  9. Responsible for maintaining Production Logbooks and overseeing entries made by Manufacturing, QA and Maintenance personnel.
  10. A minimum high school education or GED with college preferred. The position is classified as “safety sensitive” and is subject to random drug testing and background check. 

Equipment

Responsibilities to include, but not limited to:

  1. Will organize, maintain, and be responsible for support equipment including but not limited to spray nozzles, wands, mixers, fluid bed bottom screens and filters, Wurster plates, pumps, tubing, pump heads, pick up tubes, hardness testers, thickness gauges, Sweco screens, Fitzmill screens, Glatt sieve parts, VG parts and filters, pan coater nozzles and parts, CPS nozzles and parts.
  2. Work with vendors and Management to prepare RSPL (Recommended Spare Parts Lists) for equipment.
  3. Train employees on the use and care of support equipment as deemed necessary by Management.
  4. Order new support equipment based on approval of the Manager of Operations.
  5. Coordinate equipment movement with Operations Supervisors and the Warehouse.
  6. Assist Management in performing a Gap Analysis of current equipment procedures and, if deemed necessary, co-author any procedure revisions.
  7. Assist Validation Group on an as needed basis with equipment IOQs under the direction of the Manager of Operations.
  8. Review the Weekly Production Schedule and determine the equipment needs of each lab and assure required equipment is staged prior to processing and in good working order.
  9. Other tasks as assigned Supervisor and Management.

 

Tool Room 

Responsibilities to include, but not limited to:

  1.  Perform all procedural tasks as outlined in the following SOP’s:
  • SOP No. 5007.04 – Tooling Preparation.
  • SOP No. 5010.03 – Polishing of Press Tooling.
  • SOP No. 5021.03 –Tableting Tooling Receiving and Storage, Use Documentation and Inspection.
  • SOP No.  5071.00 – Cleaning Procedure for the Modu-C HH-0006.016 Capsule Filler.
  1. Clean and maintain all tablet machine punches and encapsulator machine parts.
  2. Polish punches, when necessary.
  3. Create and maintain a Tooling Log Book for each set of punches.
  4. Assign a Tooling Set Number and identify on Tooling Storage Boxes.
  5. Inspect and measure Tooling.  Document all inspection and measurements on the appropriate forms.
  6. Document Tooling usage.
  7. Report any and all Tooling damage to the Manufacturing Manager.  No Tooling is to be discarded without documentation and proper Management approval.
  8. Assure the Tool Room is locked when unattended and do not issue your access code to anyone.
  9. Perform Tooling cleaning tasks to support Manufacturing, other departments and facility readiness.
  10. Perform proper documentation in compliance with cGMP regulation and company policy in a clear and legible manner.
  11. Maintain standards of being on time to work, taking breaks and lunch at assigned times and ensuring time at work is accounted for properly.
  12. Assist Operations and Formulation with new Tooling Orders and maintain all Tooling drawings.
  13. Provide training to CM Operators on proper use and handling of compression and encapsulation Tooling.
  14. Meet with equipment vendors on an as needed basis.
  15. Responsible for following all safety rules and procedures.
  16. Other tasks as assigned by Management.

Equipment

Responsibilities to include, but not limited to:

  1. Will organize, maintain, and be responsible for support equipment including but not limited to spray nozzles, wands, mixers, fluid bed bottom screens and filters, Wurster plates, pumps, tubing, pump heads, pick up tubes, hardness testers, thickness gauges, Sweco screens, Fitzmill screens, Glatt sieve parts, VG parts and filters, pan coater nozzles and parts, CPS nozzles and parts.
  2. Work with vendors and Management to prepare RSPL (Recommended Spare Parts Lists) for equipment.
  3. Train employees on the use and care of support equipment as deemed necessary by Management.
  4. Order new support equipment based on approval of the Manager of Operations.
  5. Coordinate equipment movement with Operations Supervisors and the Warehouse.
  6. Assist Management in performing a Gap Analysis of current equipment procedures and, if deemed necessary, co-author any procedure revisions.
  7. Assist Validation Group on an as needed basis with equipment IOQs under the direction of the Manager of Operations.
  8. Review the Weekly Production Schedule and determine the equipment needs of each lab and assure required equipment is staged prior to processing and in good working order.
  9. Other tasks as assigned Supervisor and Management.

Resumes forward to: larson@jobsbl.com