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Aseptic Processing Area Mechanic - 2nd shift

American Regent, Inc Shirley Full-Time
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American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectable pharmaceutical drugs for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.  

Nature and Scope

The Aseptic Processing Area (APA) Mechanic role entails the execution of setup, breakdown, repairs, and preventive maintenance of equipment/systems used for conveying sterile containers and liquid filling of vials/ampules. 

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.  

· Setting up and breaking down sterile liquid filling machines in the Aseptic Environment 

· Troubleshooting equipment/system issues 

· Performing equipment preventive maintenance 

· Identifying and correcting unsafe conditions  

· Safety Expectations  

· Work in a safe manner using the proper Personal Protective Equipment (PPE) 

· Correct/report unsafe behaviors or equipment 

· Maintain housekeeping of own work area  

· Perform any other tasks/duties as assigned by management. 

Education Requirements and Qualifications  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.   

· Required/ Preferred Education High school diploma or equivalent vocational or trade school certification. 

· 5 years of previous relevant experience in a manufacturing working environment, Associate degree, technical diploma or applicable certifications, required.  

· 3 Years of sterile processing experience, with a concentration in filling process Advance knowledge and some ability to program PLC based control systems, preferred.  

· Use of small hand tools such as multi-meter, band saw, and drill. 

· Knowledge of 120V- 220V AC/ 3-24VDC, troubleshooting down to electronic components is a plus but not necessary. 

· Knowledge of pneumatics, solid state relays, and transformers. 

· Knowledgeable in cGMP (Current Good Manufacturing Practices) or we will train. 

· Able to read and understand engineering electrical schematics and mechanical drawings. 

· Able to follow instructions and document activities as outlined in SOPs (Standard Operation Procedures) 

· Working knowledge of PLC based control systems. 

· Willing to learn/train on the sterile liquid filling machines under aseptic processing area operations 

· Able to effectively communicate in English. 

· Able to work well with minimal supervision. 

· Basic Microsoft Office and Windows skills. 

· Ability to work overtime, night shift, and swing shift as needed. 

· Practice good personal hygiene.  

· Advanced knowledge of and ability to troubleshoot manufacturing machineries.  

· Well versed in safety programs (e.g. Lock out / Tag out, line breaking) Advanced skills including: electrical, welding, machinery troubleshooting, and mechanical equipment.  

· Ability to work overtime as needed.  

Physical Environment and Requirements

· Ability to work with full gowning in the aseptic environment 

· Ability to lift up to 40 lbs. and standing long hours during the course of work  

We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.  

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