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. Shift Schedule: Dayshift, Tuesday-Thursday, 6:00am-6:15pm with some mandatory overtime on Mondays or Fridays.

Responsibilities

• Responsible for learning the manufacturing and/or packaging process as assigned by following approved batch records, work instructions, and standard operating procedures.
• Responsible for set up, changeover, programming and operation of various equipment manufacturing and/or packaging equipment.
• Responsible for cleaning of facilities, equipment and utensils as required following SOPs and WIs.
• Responsible for completing documentation as required in the manufacturing and/or packaging of product.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, cGMPs, SOPs and Batch Record instructions.
• Responsible for performing 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

• Required: High School Diploma or equivalent.
• Preferred: Minimum of 6 months’ experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.
• Preferred: Previous pharmaceutical manufacturing or packaging experience.

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.

Education

• Requires High School Diploma or equivalent.