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

Role Summary

Production Operator II - 3rd Shift MFG, Fluid Bed/Encapsulation. This role is responsible for performing operations related to the manufacturing of drug products through equipment setup, operation, clean-up and maintenance in compliance with regulatory requirements and company policies and procedures. Shift: 3rd shift, Monday through Friday 10:00 pm to 6:30 am.

Responsibilities

• Set up, changeover and operation of fluid bed and/or encapsulation, with additional duties including 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 written 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 any conditions or problems that may affect 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 Record instructions.
• 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 MFG and/or PKG operations as applicable for position.

Skills

• Basic computer skills with MS Office, LMS, ERP systems (SAP or Oracle) and manufacturing/quality systems such as Trackwise and Qdocs.
• Ability to receive instructions and follow directions; communicate effectively in writing and verbally.
• Ability to interact positively with co-workers and management; follow company policies and regulatory requirements (cGMP).
• Ability to operate and troubleshoot production equipment; attention to detail to identify errors or inconsistencies.

Education

• High School Diploma or equivalent.

Additional Requirements

• Physical requirements related to standing, bending, reaching, lifting up to 50 lbs with assistance, and other movements as described.
• Working environment includes exposure to moving parts, moderate to loud noise, fumes, dusts, and potential need for PPE.