Manufacturing Technician II

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** 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. 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 position operates on a 2-2-3 schedule, 12 hours shifts.*
* ** Night Shift position working 6:00 pm - 6:30 am, Day shift position working 6:00 AM
-630PM.
** This position may also include the following conditions:
· 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
· Knowledge of product security controls and material handling equipment.
· Responsible for outgoing quality level
· Understand aseptic behaviours, 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 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.
· Ability to work effectively in a team environment
· Candidate should possess the ability to work in and adapt to a changing/demanding environment.
· 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
** Preferred…