Manufacturing Technician IV – Packaging Lead

Primary Responsibilities

• Lead and monitor process execution activities to ensure successful operations on the production floor.  Typical duties include leading daily Tier 1 meetings, assigning daily tasks to production technicians, monitoring material and supply levels, and coordinating production tasks such as batch execution and turnover activities.

• Act as a first-line resource for the team.  Provide support to production technicians and mechanic technicians.  Resolve production-related issues such as batch set-up, execution, technical intervention, documentation, equipment operations, line SOPs, and safety and quality inspection procedures.

• Perform inventory control and reconciliation activities, which will require the use of SAP and WES in a limited role.

• Perform technician tasks as required including start-up, equipment operation, manual packaging, batch execution, material handling, rework, quality inspection, cleaning, housekeeping and line clearance activities.

• Manage batch records and GMP documentation on the production floor.  Review documentation for completeness and accuracy per GxP standards within established timelines.  Assist and train others to complete documentation as required.

• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls.

• Ensure work requirements are followed on the production floor, in accordance with SOPs and established safety and quality procedures.

• Work alongside Process Facilitators and Engineers, creating ancollaborative environment for all Packaging associates.

Other Responsibilities

• Support lean activities such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.  Lead Level 0 problem-solving on process related issues and generate OPL communications as needed.

• Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train and conduct evaluations on other team members for training qualifications.

• Review process documents such as operational SOPs, forms and batch records for accuracy.  Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.

• Execute protocols as required as a part of equipment qualification and process validation work

• Be flexible and support other work areas within the Team as needed

• Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.

• Minimum Requirements: 

  • Must have the ability to effectively understand, read, write, communicate and follow instructions. 

  • Good attention to detail is required.

  • Individual must be capable of keeping accurate records and performing mathematical calculations

  • Experience working in a GMP environment

  • Preferred Background: 

  • Experience in a pharmaceutical or high speed packaging production environment

  • High school graduate, vocational school graduate or equivalent  

  • Working knowledge of Microsoft applications, SAP and Veeva Vault 

  • Experience working in a LEAN manufacturing environment 

  • Knowledge of cGMPs and FDA policies/procedure