Independently performs routine tasks and troubleshooting in the areas of Vial Inspection, Vial Packaging, and Syringe Packaging.
This includes but it is not limited to Operation and troubleshooting of all Vial Inspection & Packaging equipment as well as Syringe Packaging equipment.
Operate and troubleshoot high-speed automated Inspection and Packaging equipment. Typical tasks include loading vials/syringes onto automated inspection equipment, changing label reels, replenishing packaging items (e.g. inserts, labels, cartons, trays, and shippers), operating vial inspection machines, labeler, cartoner, case palletizer, serialization equipment, and wrapping pallets.
Participate in line changeovers and continuously strive to minimize line downtime and maximize OEE%.
Maintains and completes batch record documentation and logs as required by corporation and regulatory agencies.
Performs cleaning of production equipment and production space.
Provides instructions and guidance to less experienced technicians.
This job will also entail transfer towers, racks, and pallets of filled/packaged vials.
Perform routine daily and weekly cleaning of manufacturing area.
Will serve as witness of routine unit operation tasks for batch record signing. Performs all entries following ALCOA principles (Accurate, Legible, Contemporaneous, Original, Attributable). Maintains all associated documentation for operations being performed. Will May participate in be assigned formal FMEAs, RAs, CAPAs, CCRs, NCRs, and Action Items as needed.
Applies acquired skills while performing the most complex tasks of the position, following established practices and procedures. Demonstrated ability to apply experience to perform equipment troubleshooting and to suggest procedurall revisions, as needed. Adheres to production schedule requirements. Ensures compliance with cGMPs and SOPs at all times.
Generally receives minimal instructions on all assignments with some supervision. Takes initiative to identify issues, troubleshoot, propose solutions, and keep management informed.
Based on production schedules, random and different start time scenarios may occur so a very flexible work schedule is required for the candidate. Ability to accommodate production requirements that may require 50+ hour workweeks, including extended day hours and weekend. This role requires periodic work on weekends depending on production demands.
Ability to stand for several hours at a time, bend, squat, and reach
Ability to lift, push or pull various amounts of weight