Operator I

Role Summary

This position is responsible for performing operations related to the manufacturing and/or packaging of pharmaceutical products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory cGMP requirements and company policies and procedures in primary and secondary packaging or manufacturing.

Responsibilities

• Learn the manufacturing and/or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc.
• Set up, changeover, programming and operation of various equipment manufacturing and/or packaging equipment including, but not limited to, R&D operator work.
• Clean facilities, equipment and utensils as required following SOPs and WIs.
• Complete documentation as required in the manufacturing and/or packaging of product.
• Complete all training requirements and maintain 100% compliance with all assignments.
• Maintain work areas and perform job functions in a safe and efficient manner in accordance with company policies and procedures, cGMPs, SOPs and Batch Record instructions.
• Perform additional related duties as assigned.
• Must be able to wear a PAPR during shift.
• Must be able to go up and down steps in the production rooms frequently throughout the shift.

Qualifications

• Equivalent combination of education, training and/or experience acceptable; preferably previous pharmaceutical manufacturing or packaging experience.

Education

• Requires High School Diploma or equivalent.
• Prefer a minimum of 6 months previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.

Skills

• Ability to receive instruction and follow directions.
• Ability to interact positively with co-workers and management.
• Ability to communicate effectively with written and oral communication skills.
• Ability to follow company policies and procedures.
• Ability to follow cGMP and other regulatory requirements.
• Ability to maintain 100% compliance in all SOP, cGMP, EHS and other training curriculum as assigned.
• Ability to operate and troubleshoot manufacturing/packaging equipment.

Additional Requirements

• Physical demands include wearing a PAPR and frequent stair navigation within production areas.