Role Summary
Process Operator (USA - North Carolina - Zebulon) responsible for operating, challenging and cleaning equipment in accordance with SOPs, JSAs and batch documents to deliver high-quality products safely. You will monitor equipment for excessive rejects, resolve minor downtime, and identify improvement opportunities to drive efficiency. You will perform changeovers and setup to design specifications in a regulated environment compliant with OSHA requirements.
Responsibilities
- Operates, challenges, replenishes consumable supplies, cleans equipment, and all duties needed by the business in accordance with cGMPs, Batch Documentation, SOPs, ZSPs and JSAs, maintaining inspection readiness of the area with minimal supervision.
- Actively monitors equipment for excessive rejects and stoppages, and uses performance data to escalate problems affecting product quality, safety, and line performance.
- Trained in the GSK Production System standards (5S, standard work, problem solving, Gemba, process confirmations, and performance management) toward Zero Accidents, Zero Defects, and Zero Waste.
- Participates in performance management entry, steps 1–3 of problem solving, and maintaining OSW and 5S.
- Delivers against safety, quality, waste and performance objectives defined by strategy deployment and identifies areas for process improvement or alternative operating methods to increase efficiency.
- Recognized as an expert on operations/process with the ability to troubleshoot and resolve minor equipment production stoppages.
- Operator possesses considerable knowledge of the job and is reliable and able to produce high quality and high quantity work.
- Utilizes systems/applications required for job performance (i.e., DELTA, my Learning, Free Weigh, DISY, Active Plant, IP21, SAP basic transactions for meeting production supply, etc.).
- Works in coordination with other associates, assistants, and/or technicians to carry out daily job responsibilities, including recognizing and assisting with troubleshooting technical issues and providing information to the next supervisory level.
- Demonstrates the ability to describe the technological theory of operation, product flow through equipment, and able to identify the function and purpose of all sensors, limit switches, and proximity sensors.
- Demonstrates the ability to conduct equipment set up changeovers and start of batch activities to the designed specifications without start up issues. Ability to certify on multiple technologies and flow to the work as needed by the business.
Qualifications
- Required: High School Diploma or GED
- Required: 1+ years pharma/manufacturing experience
- Required: Must be able to handle up to 40 lbs. of materials
- Required: Ability to work up to 12.5 hrs. in one shift (If required)
- Preferred: Ability to work accurately with figures and information
- Preferred: Ability to use and analyze data effectively
- Preferred: Mechanically inclined with the ability to learn the operation, read gauges and instrumentation, and any equipment related to the production of medical devices and/or pharmaceutical products
- Preferred: Knowledge of Overall Equipment Effectiveness (OEE)
- Preferred: Competent to perform data entry, utilize computers and HMIs
- Preferred: Knowledgeable of all applications to the area (i.e., DELTA, my Learning, Free Weigh, DISY, Active Plant, IP21, SAP basic transactions for meeting production supply, etc.)
Skills
- Basic reading, writing and mathematical skills
- Basic computer skills and proficiency with MS Word and MS Excel
- Ability to work accurately with figures and information
- Ability to use and analyze data effectively
Additional Requirements
- Ability to climb, kneel, stoop, balance, crawl, crouch, reach, sit, stand, walk, push, pull, grasp, feel, talk, hear, lift, and perform tasks as defined by the specific role.
- Ability to work overtime as needed.
- Must wear gloves, eye protection, and protective clothing as required by the specific job role.
- Ability to learn at a rapid pace to support training module expectations; work inside a manufacturing environment with potential exposure to noise, moving parts, and drug compounds as the role mandates.
- Must be able to flow to the work as needed and operate in a high-energy, fast-paced environment.