Manufacturing Technician II - PET (Dayshift)

Position Summary & Responsibilities

The Manufacturing Technician II reports to a Process Execution Team (PET) Supervisor/Manager on the Manufacturing floor, which supports Filling operations. This position will require working in various Controlled/Non-Classified and Classified areas.

• Operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPs.
• Performs the duties of operating assigned machinery consisting of servicing filling machines with materials, removing finished materials from machine tables, and assuring the smooth flow of product.
• Assembles, disassembles, operates and sanitizes various Filling equipment.
• Performs and executes filter integrity testing as needed per SOP.
• Completes cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
• Starts up and makes minor adjustments to machinery as needed.
• May perform computer on-line data input, including SCADA and HMI entries.
• Performs visual and physical checks of in-process and finished materials as requested.
• Works with various printing devices including printing mats.
• Enters batch records and GMP documentation entries.
• Maintains records and/or logs as required in the performance of job responsibilities, including mathematical computation where needed.
• Understands product security controls and material handling equipment.
• Responsible for outgoing quality level.
• Understands aseptic behaviors, media fills including line interventions, and has a basic knowledge of viable and non-viable monitoring equipment.
• Performs inventory control and reconciliation activities, which may require the use of SAP in a limited role.
• Supports lean activities and process improvement work such as performing 5S in the work area and Single Minute Exchange of Die (SMED).
• Participates in problem-solving and manual tracking of performance data for OEE and process improvement analysis.
• Executes Validation/Engineering protocols for processes/equipment.
• Identifies and provides suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
• Flexible in training and support other Filling functions as needed.
• Performs all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.
• Acquires and maintains all required certification and qualifications for the assigned work area.
• 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.

Minimum Qualifications

• Ability to effectively understand, read, write, communicate, and follow instructions in the English language.
• Good attention to detail is required.
• Individual must be capable of keeping accurate records and performing mathematical calculations.

Preferred Qualifications

• High school graduate, vocational school graduate, or equivalent.
• Prior production experience.
• Experience in a pharmaceutical or cGMP regulated environment.
• Experience working in a LEAN manufacturing environment.
• Knowledge of cGMPs and FDA policies/procedures.