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.

• Operate equipment, perform in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and complete batch record entries in accordance with cGMPs.
• Perform duties of operating assigned machinery, including servicing filling machines with materials, removing finished materials from machine tables, and ensuring the smooth flow of product.
• Assemble, disassemble, operate and sanitize various Filling equipment.
• Perform and execute filter integrity testing as needed per SOP.
• Complete cleaning and housekeeping activities for assigned areas to maintain a cGMP environment.
• Start up and make minor adjustments to machinery, perform computer on-line data input, including SCADA and HMI entries.
• Perform visual and physical checks of in-process and finished materials as requested.
• Work with various printing devices, including printing mats.
• Enter batch records and GMP documentation entries.
• Maintain records and/or logs as required in the performance of job responsibilities, including mathematical computations where needed.
• Understand product security controls and material handling equipment.
• Ensure outgoing quality levels and understand aseptic behaviors, media fills, and have a basic knowledge of viable and non-viable monitoring equipment.
• Perform inventory control and reconciliation activities, which may require the use of SAP in a limited role.
• Support lean activities and process improvement work such as performing 5S in the work area and Single Minute Exchange of Die (SMED).
• Participate in problem-solving and manual tracking of performance data for OEE and process improvement analysis.
• Execute Validation/Engineering protocols for processes/equipment.
• Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
• Be flexible in training and support other Filling functions as needed.
• Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.
• Acquire and maintain all required certifications and qualifications for the assigned work area.
• Capable and motivated to learn new skills and develop new capabilities on an ongoing 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.