Manufacturing Technician III-Filling

Brief Job Description

The Manufacturing Technician III is a position reporting to a Process Execution Team (PET) Process Facilitator, which supports Filling operations. The position entails the execution of setup, changeover, repairs and preventative maintenance for all equipment used in the production processes in various Controlled/Non-Classified and Classified areas up to a Class 100 (Grade A) aseptic environment. It requires the ability to perform mechanical and electronic troubleshooting in order to ensure optimal operation of equipment via OEE. The Manufacturing Technician III will also provide basic mechanical training to Technicians and serve as a resource for implementation of continuous improvement projects.

Job Responsibilities

Primary Responsibilities

• Set-up equipment and perform required adjustments to ensure each operation is performing per process specifications.

• Install, inspect, test, adjust, repair and perform line turnarounds, changeovers, and interventions per established procedures in a timely and efficient manner.

• Resolve equipment-related issues utilizing appropriate problem solving and troubleshooting techniques

• Responsible for OEE performance of all equipment and systems within the assigned operating area.

• Working knowledge of inspection equipment.

• Label and deliver samples and microbiological sampling plates to appropriate locations.

• Responsible for assembling, testing, disassembling, and sanitizing various equipment.

• Label microbiological sampling plates and deliver to specified locations if applicable.

• Assist technical staff as required with preventive maintenance procedures

• Obtain/maintain sterile gowning qualification for sterile core Mechanic Technician.

• Understand aseptic behaviours, media fills including line interventions, and have a basic knowledge of viable and non-viable monitoring equipment.

• Perform technician tasks as required including start-up, equipment operation, batch execution, material handling, cleaning, housekeeping and line clearance activities

• Follow and maintain compliance with established procedures and inventory control.

• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.

• Perform batch record and GMP documentation entries. Maintain records and/or logs as required in 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.

• 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.

• 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.

Other Responsibilities

• Support lean activities and process improvement work such as performing 5S in the work area, and Single Minute Exchange of Die (SMED) activities in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.   Lead Level 0 problem-solving on equipment related issues as needed.

• Act as an OJT trainer on the team for equipment set-up, operations and for minor adjustments or repairs.

• Serve as a project resource to PET to assist in the follow up and timely implementation of projects and validation activities.

• Be flexible and support other work areas, perform other similar and related responsibilities as assigned by area management

• Perform all other assigned duties with minimal supervision under the direction of the Process Facilitator, Maintenance Facilitator, Engineer, or other activity lead.

Competencies & Job Requirements:

• Acquire and maintain all required certifications and qualifications for the assigned work area

• Maintain Aseptic Processing and Gowning certifications as required

• Strong verbal and written communication skills

• Proven ability to work effectively in a team environment

• Strong mechanical and technical knowledge and aptitude

• Ability to interpret technical documents

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

• Overtime may be required with minimal notice to ensure operation of equipment within the PET.

Education, Qualifications, Skills and Experience

Minimum Requirements:

• High school graduate, vocational school graduate or equivalent

• Minimum three years of experience in a regulated production environment, specifically responsible for equipment maintenance and performance

• Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.

• Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair

Preferred Background:

• Associates in Engineering or a related discipline or equivalent mechanical trade school graduate preferred

• Previous experience with automated equipment preferred

• Training in mechanics, hydraulics, electronics and testing equipment in electrical and/or mechanical troubleshooting

• Knowledge of computerized maintenance management system such as SAP

• Experience with OEE, TPM, LEAN or other Continuous Improvement methodology