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

Role Summary

Production Operator II - 3rd Shift MFG, Fluid Bed/Encapsulation. Responsible for performing operations related to the manufacturing of drug products through equipment set-up, operation, clean-up and maintenance in compliance with regulatory requirements and company policies and procedures. This role works on the 3rd shift (Mon–Fri, 10:00 pm–6:30 am) in the Manufacturing Department.

Responsibilities

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

Qualifications

• Required: High School Diploma or equivalent.
• Required: 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.

Skills

• Basic computer skills with MS Office, LMS, ERP systems (SAP or Oracle) and Trackwise/Qdocs.
• Ability to receive instructions and follow directions.
• Effective written and verbal communication; positive interaction with co-workers and management.
• Ability to follow company policies, cGMP and regulatory requirements.
• Ability to operate and troubleshoot production equipment; detail-oriented to identify errors.

Education

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

Additional Requirements

• Physical requirements include standing, walking, finger dexterity, stooping/kneeling, twisting/reaching, occasional lifting up to 50 lbs with assistance, and PPE as needed.
• Working environment includes exposure to moving parts, noise, fumes/dust, vibrations, and potential wetness depending on process.