Operator

Role Summary

Operator 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. This role supports learning the manufacturing and/or packaging process and adheres to approved batch records, work instructions, and SOPs.

Responsibilities

• Responsible for learning the manufacturing and/or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc.
• 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.

Qualifications

• Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Preferably previous pharmaceutical manufacturing or packaging experience.
• Requires High School Diploma or equivalent.
• Prefer 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.

Education

• High School Diploma or equivalent.
• Prior experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries preferred.

Additional Requirements

• Physical requirements include standing for extended periods, walking, stooping, kneeling, reaching, sitting, climbing, pushing/pulling, repetitive motions, and lifting 25‚Äì50 lbs (with assistance for more than 50 lbs).
• Visual acuity for computer work, data preparation, and inspection of small parts and defects.
• Location and shift: Shift schedule often includes Tuesday‚ÄìThursday 6am‚Äì6:30pm, with potential Friday hours; location in a pharmaceutical manufacturing setting.