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

Role Summary

Production Operator II - 3rd Shift MFG, Fluid Bed/Encapsulation. 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. Work will be in the Manufacturing Department on a 3rd shift (Monday–Friday, 10:00 pm to 6:30 am).

Responsibilities

• Set up, changeover, and operation of fluid bed and/or encapsulation equipment; 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 for manufacturing, cleaning of facilities and equipment, following cGMP 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, cGMP, 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 environments.
• Prefer Teva certification in one or more manufacturing and/or packaging operations as applicable.

Skills

• Basic computer skills with MS Office, LMS, ERP systems (e.g., SAP or Oracle) and manufacturing/quality systems (Trackwise and Qdocs).
• Ability to receive instructions and follow directions; positive interaction with coworkers and management.
• Effective written and oral communication; ability to follow policies, procedures and regulatory requirements (cGMP).
• Ability to operate and troubleshoot production equipment; detail-oriented with strong error/variance identification.

Education

• High School Diploma or equivalent.
• Experience with fluid bed and/or encapsulation in relevant industries.

Additional Requirements

• Physical requirements include standing for extended periods, walking, fingering, stooping, kneeling, reaching, lifting up to 50 lbs with assistance, and other movements as described. PPE usage may be required.
• Working environment includes exposure to moving mechanical parts, noise, fumes/dust, vibrations, and wetness depending on process.