Packaging Manufacturing Operator

Johnson & Johnson•Gurabo, PR

2d•Onsite

About The Position

The "Packaging Manufacturing Operator" masters parenteral manufacturing operations in at least four or more of the following processes: formulation, preparation of equipment and components, sanitization of areas and equipment, aseptic filling, lyophilization, sealing, inspection, and packaging. Executes and documents in accordance with cGMP policies and practices, EHS in procedures, manufacturing records, and SAP inventory control systems, whether automated or electronic, as well as manual. Performs diagnosis of medium complexity mechanical or electronic failures in the equipment of the operational areas under their responsibility. Trains new personnel or colleagues as part of the cross-training program. Must be the Subject Matter Expert (SME) and mentor in the processes under their responsibility. May coordinate activities and personnel within the functional area of their responsibility.

Requirements

Technical Degree in Industrial, Electricity, Instrumentation, or Electronics, or in another related field is required.
Two (2) years of experience in the pharmaceutical or related industry is required.
Availability to work 1st, 2nd, 3rd, and 4th shifts.
Additionally, must have flexibility to change shifts or work week, work overtime, weekends, and holidays according to business needs is required.

Nice To Haves

Bachelor's Degree in Administration, Sciences, Engineering, or a related field is preferred.

Responsibilities

Executes and masters production activities and operates machinery in (4) or more Parenteral manufacturing and packaging functional areas.
Assists maintenance technicians and/or performs preventive and/or corrective maintenance tasks.
Performs basic troubleshooting and/or assists maintenance technicians in troubleshooting equipment in their functional area.
Keeps records of the operations of the equipment and systems of the assigned functional area.
Documents, reviews, and verifies equipment calibrations (scales, control equipment, instrumentation, etc.) before use, in accordance with current procedures.
Ensures that all components to be used are approved and meet specifications.
Weighs raw materials and excipients and verifies that their appearance, expiration date, and lot number comply with work orders and specifications before starting the weighing and/or manufacturing process.
Executes manufacturing and packaging activities in all business units, following corresponding instructions and documenting these actions in the appropriate manual or electronic manufacturing records (ePES, SAP).
Performs and documents the final inventory of used material and rejected material in the corresponding e-PES, SAP system.
Performs and documents the reconciliation of the different stages of product manufacturing according to manufacturing instructions.