Manufacturing Tech III
SHIFT - Monday - Friday 7AM-3PM Knowledge:
Knowledge of written Standard Operating Procedures (SOPs) and Master Batch Records
Good verbal, written, and interpersonal communication skills are required.
Working knowledge in Microsoft Office applications and administrative policies
Ability to follow direction and work under minimal supervision
Demonstrates capability in training others on a manufacturing process (e.g. filling, hydration, coating, granulation, compression)
Demonstrates capability in organizing more complex activities in a manufacturing process.
Specific education and experience requirements:
3+ years of relevant experience, HS Diploma and a Certificate to FETAC level 6 (GSL)
Prior experience in a cGMP related industry is required.
Specific job responsibilities:
Works on basic to routine assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs).
Performs moderately complex tasks associated with aseptic processing, dispensing, compaction, granulation, milling and coating.
Reports to Team Lead on a regular basis on line performance and reports any issues that need to be resolved.
Performs more complex troubleshooting unassisted
Works on more complex manufacturing processes and assignments
Assembles, disassembles and operates aseptic filling equipment and lyophilizer autoloading equipment in classed cleanroom environments.
Prepares equipment and components for sterilization.
Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnel.
Cleans (manually and clean-in-place) and assembles equipment for production.
Performs clean-in-place and sterilization-in-place of tanks.
Performs annealing and sterile filtrations of products.
Operates vial capper, unloads product from lyophilizers, and packs off unloaded vials from lyophilizers and liquid fill line.
Performs detailed /Oracle (computerized software) and MES transactions in resolving inventory discrepancies.
Cleans manufacturing areas, including walls, ceilings and floors.
Creates purchase orders for consumables.
Completes and maintains documentation related to assigned work, including logbooks, batch records, etc.
May act as point of contact for a compliance audit.
Operates drum coater and compression equipment.
Dispenses ingredients for batches.
Performs MBR Manufacturing batch report updates.
Performs manual handling of product – loads and unloads tablets.
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