Operator I

Role Summary

This role performs manufacturing and/or packaging operations for pharmaceutical products, including equipment setup, operation, cleaning, and maintenance, in accordance with cGMP and company procedures. It supports primary and secondary packaging or manufacturing activities and requires following approved batch records, work instructions, and SOPs. The position emphasizes safety, compliance, and accurate documentation.

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.
• Cleaning of facilities, equipment and utensils as required following SOPs and WI’s.
• Completing documentation as required in the manufacturing and/or packaging of product.
• Completing all training requirements and maintaining 100% compliance with all assignments.
• Maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Performing additional related duties as assigned.

Qualifications

• Required: High School Diploma or equivalent.
• Preferred: 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.
• Problem solving: Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required; exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions. Normally receives general instruction on routine work and detailed instruction on new assignments. May be asked to recommend methods and procedures for problem resolution.

Education

• High School Diploma or equivalent.

Additional Requirements

• 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.