Manufacturing Technician 2

The Manufacturing Technician II is a direct labor position reporting to a Process Execution Team (PET) Manager on the Manufacturing floor, which supports Filling operations. This position will require working in various Controlled/Non-Classified and Classified areas. The Filling Technician operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPs.

**This is a Day (A) Shift, 12-Hour Rotating Schedule 6am - 6:30pm 2-2-3 schedule**

Position Responsibilities:

• Perform 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.
• Responsible for assembling, disassembling, operating and sanitizing various Filling equipment.
• Perform and execute filter integrity testing as needed per SOP.
• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
• Be able to start up and make minor adjustments to machinery.
• Computer on-line may require some data input. This includes 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.
• Perform batch record and GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed.
• Responsible for outgoing quality level.
• Understand aseptic behaviors, media fills including line interventions, 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.
• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with “Material Safety Data Sheets” for area chemicals.
• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process facilitator.
• Assist mechanical staff with preventive maintenance procedures, as required.
• Support lean activities and process improvement work such as performing 5S in the work area and ,Single Minute Exchange of Die (SMED), participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
• Assist with executing 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.
• Some overtime may be required with minimal advance notice to support business needs

Minimum Qualifications:

• Must have the 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.
• 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
• Ability to work effectively in a team environment
• Candidate should possess the ability to work in and adapt to a changing/demanding environment
• Candidate must attain aseptic gowning qualification during training and be able to aseptically gown on a regular basis.

Preferred Qualifications:

• High school graduate, vocational school graduate or equivalent
• 1 Year of experience in a pharmaceutical or cGMP regulated environment
• Prior production experience
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures
• Knowledge of product security controls and material handling equipment.