Operate, monitor, troubleshoot, and perform maintenance tasks on various packaging equipment including picker, sorter, labeller, packer, checkweigher, printer, inspection equipment, palletizer, stretch-wrapper and conveyors. Work collaboratively with technical resources to resolve equipment issues as needed.
Act as a first-line technical resource for the team. Provide technical support to production technicians. Resolve equipment-related issues, including equipment start-up, machine recipe selection, recipe format set-up, critical sensor challenge, and production issues.
Proactively monitor equipment and component level conditions, and perform preventative maintenance tasks. Identify and investigate abnormal conditions and potential defects to prevent unplanned equipment downtime.
Perform technician tasks as required including start-up, equipment operation, manual packaging, batch execution, material handling, rework, cleaning, housekeeping and line clearance activities.
Operate light material handling equipment (motorized and manual pallet jacks, non-motorized lifts) as the need arises to safely move, store or deliver material to the proper location.
Monitor material quality of incoming, in-process and finished materials. Promptly escalate concerns to Lead Technician and Process Facilitator as needed.
Perform batch records, GMP documentation, and CMMS 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.
Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs, and established safety and quality procedures.
Other Responsibilities
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. Lead Level 0 problem-solving on equipment related issues as needed.
Act as a certified OJT trainer on the team on assigned equipment or process tasks. Train and conduct evaluations on other team members for training qualifications.
Review process documents such as operational SOPs, PM procedures, 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 Process Execution Team as needed
Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.
Competencies & Job Requirements
Acquire and maintain all required certifications and qualifications for the assigned work area
Strong mechanical and electronic knowledge and aptitude
Strong verbal and written communication skills
Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution Team
Proven ability to work effectively in a team environment
Ability to interpret technical documents
Candidate should possess the ability to work in and adapt to a changing/demanding environment
Some overtime may be required with minimal advance notice to support business needs.
Minimum Requirements
Must have experience in a regulated production environment, specifically responsible for equipment maintenance and performance
Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair
Preferred Background
High school graduate, vocational school graduate or equivalent
Minimum three years experience in a regulated production environment, specifically responsible for equipment maintenance and performance
Associates in Engineering or mechanical trade school graduate preferred
Previous experience with automated equipment
Training in mechanics, hydraulics, and electronics systems
Knowledge of computerized maintenance management system such as SAP
Experience with OEE, TPM, LEAN or other Continuous Improvement methodology
