Manufacturing Technician II-Filling

Brief Job Description

The Manufacturing Technician II is a direct labor position reporting to a Process Execution Team (PET) Process Facilitator 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.

Job Responsibilities

Primary 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.

Other Responsibilities

• 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.

Competencies & Job Requirements:

• 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

• 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

Education, Qualifications, Skills and Experience

Minimum Requirements:

• High school graduate, vocational school graduate or equivalent

• 1 Year of experience in a pharmaceutical 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.

Preferred Background:

• Prior production experience

• Experience working in a LEAN manufacturing environment

• Knowledge of cGMPs and FDA policies/procedures