Production Operator II - 3rd Shift MFG, Fluid Bed/Encapsulation

Role Summary

This position is responsible for performing operations related to the manufacturing of drug products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory requirements and company policies and procedures. This role is in the Manufacturing Department on 3rd Shift, Monday through Friday 10:00 pm to 6:30 am.

Responsibilities

• Set up, changeover and operation of fluid bed and/or encapsulation; additional duties may include mixers, granulators, dryers, mills and tablet compression.
• Demonstrate consistent and proficient performance in certified areas of operation as applicable.
• Troubleshoot machine parts and equipment in certified areas of operation as applicable.
• Train lower level technicians to perform manufacturing operations as applicable.
• Clean facilities, equipment and utensils following SOPs and Work Instructions.
• Complete documentation in the manufacturing of product and cleaning of facilities and equipment following cGMPs and good documentation practices.
• Report and/or escalate conditions or problems affecting product quality or integrity.
• Complete all training requirements and maintain compliance with assignments.
• Maintain work areas and perform job functions safely and efficiently in accordance with policies, cGMPs, SOPs, and Batch Records.
• Perform additional related duties as assigned.

Qualifications

• Requires High School Diploma or equivalent.
• Requires fluid bed and/or encapsulation experience in pharmaceutical, food processing, or chemical manufacturing.
• Preferred Teva certification in one or more manufacturing and/or packaging operations as applicable for the position.

Skills

• Basic computer skills with working knowledge of MS Office, LMS, ERP systems (e.g., SAP or Oracle), and manufacturing/quality systems (Trackwise, Qdocs).
• Ability to receive instruction and follow directions.
• Positive interaction with co-workers and management.
• Effective written and oral communication.
• Ability to follow company policies, procedures and regulatory requirements (cGMP).
• Ability to operate and troubleshoot production equipment.
• Detail-oriented with ability to identify errors and inconsistencies.

Education

• High School Diploma or equivalent.
• Experience with fluid bed and/or encapsulation in relevant industries.
• Teva certification in manufacturing/packaging operations (preferred).

Additional Requirements

• Constant exposure to moving mechanical parts and equipment; moderate to loud noise; fumes, odors, dusts, mists and gasses; vibrations; PPE as needed.
• Physical demands include standing, walking, fingering, stooping, kneeling, reaching, sitting, climbing, crawling, pushing/pulling, grasping, repetitive motions, and lifting up to 25‚Äì50+ lbs with assistance.