Manufacturing Technician II - Filling (Nights)

Resilience•West Chester, OH

1d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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.
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 certifications and qualifications for the assigned work area.