Manufacturing Technician 2

This position reports to Supervisor/Manager of Manufacturing on the Manufacturing floor, which supports Sterile 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.

**This is a Day Shift - (6a - 6:30p, 2 days on, 2 days off, 3 days on, 3 days off) 12-Hour Rotating 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.

• 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 

• Some overtime may be required with minimal advance notice to support business needs.

Minimum Qualifications

• Experience in a pharmaceutical and/or cGMP regulated environment 

• 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.

• Ability to work effectively in a team environment 

• Candidate should possess the ability to work in and adapt to a changing/demanding environment.

Preferred Qualifications

• High school graduate, vocational school graduate or equivalent 

• Prior production experience 

• Prior Aseptic Manufacturing Experience 

• Experience working in a LEAN manufacturing environment 

• Knowledge of cGMPs and FDA policies/procedures

• Knowledge of product security controls and material handling equipment.