Production Technician

Position : Production Technician | 3659-1

Duration : 6+ months

C shift from 5 : 45 PM - 6 : 15 AM

Job Description

The technician will be responsible for assembling, operating, and monitoring state-of-the-art, aseptic equipment following applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of and practice good aseptic techniques to minimize the potential for product contamination as well as understand advanced computerized systems through HMI.

Ability to operate advanced HMI applications.

Perform basic level machine operation, set-up and troubleshooting of all state-of-the-art equipment in their area (may include Vial Washer, Dehydrogenation Tunnel, Filling Machine, Isolator, Stopper Loading Systems, Capping Machine, Glove Tester, Automatic Loading & Unloading System (ALUS), Lyophilizers, Parts Washers, Component Sterilizes, Stopper Cans, Filter Integrity Tester, Vaporized Hydrogen Peroxide Transfer Hatcht tö meet process parameters

Load Parts Washer, Component Sterilizer, Vial Washer, Filling Machine and Capping Machine with raw materials and format parts

Practices and understands aseptic manufacturing principles

Maintains gown qualification if required by their area

Perform microbiological monitoring within the Filling Machine, ALUS, and Capping Machine

Assist other departments including MQA, Maintenance, Metrology, Engineering, Validation, Tech Transfer and Microbiology, with tasks on the equipment in their area General

Clean and sanitize equipment and Production areas per SOP

Transfer raw materials, operating supplies, and finished product in and out of the manufacturing areas

Multi-task and learn multiple manufacturing areas

Train and comply with current SOPs and GMPs

Documents work accurately and timely

Understand the process flow and step by step requirements for manufacturing

Work in a time efficient manner while maintaining adherence to all applicable SOPs

Concise communication with co-workers and managers to promote a teamwork atmosphere

Perform other duties as directed

Perform Daily (Floors), Weekly (Walls and Floors), and Monthly (Ceiling, Walls and Floors) cleanings of the manufacturing areas

Perform cleanings / clearance of the equipment and room for pre-clearance / post-clearance of a batch

Restock operation supplies and gowning materials in Production areas

Any other tasks requested by Supervisor or Group Leader

Requirements

Have a minimum of a High School Diploma, GED, or equivalent education with one year of experience in a relevant work environment

Able to work 12hr shifts on a 2-2-3 schedule

Able to stand on concrete floors for an extended period of time

Able to lift up to 35 pounds by bending and lifting

Able to move heavy equipment and components as needed

Able to work with hazardous materials including antineoplastic products and raw materials that could lead to serious illness / injury

Able to wear required personal protective equipment (eye protection, safety shoes, gown, gloves)

Must be able to understand, speak, and write English in order to comply with necessary SOPs, SPECs, Job-specific training materials, GMPs, and other manuals

Preferred

Experience in Pharmaceutical or Food Industries

Experience using Aseptic Technique

Basic and / or advanced math skills

Basic mechanical knowledge (hands-on troubleshooting and adjusting equipment)