Manufacturing Technician II - Packaging (Nights)

Job Responsibilities

• Operate assigned machinery, servicing machines with materials, monitoring equipment status, reintroducing materials, manually palletizing finished materials, and ensuring a smooth flow of product.
• Start-up machinery, including equipment setup, recipe selection, and data entry on manufacturing computerized systems (SCADA and HMI), making minor adjustments, and performing critical sensor challenges.
• Perform manual packaging tasks, including hand packaging and rework of in-process and finished material.
• Operate light material handling equipment (motorized and manual pallet jacks, non-motorized lifts) to safely move, store, or deliver material to the proper location.
• Perform visual quality inspection and sampling of in-process materials.
• Promptly escalate concerns to Lead and Process Facilitator as needed.
• Perform minor troubleshooting, including clearing minor jams and identifying equipment defects.
• Work collaboratively with technical resources to resolve equipment issues as needed.
• Perform inventory control and reconciliation activities, which may require the use of SAP and WES in a limited role.
• Perform cleaning, housekeeping, and line clearance activities for assigned areas to maintain a cGMP environment.
• This includes assembling, disassembling, and sanitizing various packaging equipment.
• Perform batch record and GMP documentation entries.
• Perform mathematical computation as needed.
• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls.
• Report all discrepancies to process facilitator.
• Support lean activities and process improvement work such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
• 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 Manufacturing Team as needed.

Requirements

• Experience in a pharmaceutical or cGMP regulated environment.
• Ability to effectively understand, read, write, communicate, and follow instructions in the English language.
• Good attention to detail is required.
• Working knowledge of Microsoft applications and SAP.
• Prior production experience.
• Experience working in a LEAN manufacturing environment.
• Knowledge of cGMPs and FDA policies/procedures.

Qualifications

• High school graduate, vocational school graduate or equivalent.
• Certified to operate assigned equipment and processes.