POSITION SUMMARY

High-level position for persons to manufacture commercial scale batches.

MAJOR RESPONSIBILITIES

• Lead other operators and small groups as directed by the Supervisor.
• Production, filling, and inspection of pharmaceutical formulations.
• Assist with facility cleaning and operational maintenance.
• Assist with facility and process validations as required.
• Perform aseptic production operations and validations.
• Assist with environment and water system monitoring as required.
• Assist with clean room sanitization as required.
• Assist with RCRA and safety inspections as required.
• Document all work as required by CGMPs on a timely basis.
• Read and follow all company SOPs and guidelines.
• Abide by all safety requirements as defined by the company.
• Train newly qualifying personnel.
• Provide coaching and feedback for currently qualified personnel.
• Other tasks as assigned by the Supervisor.

COMPETENCIES

• General knowledge of the Scientific Method.
• General math skills, including simple algebra.
• Through knowledge of and adherence to Current Good Manufacturing Practices.
• General knowledge of chemistry and biology.
• General knowledge of steam/dry heat sterilization theories.
• General knowledge of HAZCOM, RCRA, and other Safety requirements.
• Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment.
• General computer word processing/spreadsheet skills.
• General knowledge of and ability to participate in customer, internal and FDA audits.
• Excellent documentation skills.
• Ability to act in a leadership role as production situations demand.
• Ability to mentor newly hired and progressively qualifying personnel.
• Detail oriented.
• Willing to learn new tasks and skills.
• Works well in a team environment.
• Respond quickly to assignments.
• Readily adapts to changing job duties.
• Manages time well; ability to multi-task.
• Positive attitude.
• Effective written and verbal communication skills.
• Effective trainer (coach).
• Displays understanding of and promotes company and customer objectives.

Physical Requirements:

• Occasional periods of repetitive motion.
• Ability to gown in an aseptic manner for clean room operations. 
• Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. 
• Ability to operate all types of production equipment 
• Ability to read, understand, and follow company SOP guidelines.
• Ability to lift/move up to 50 lbs.  Ability to team lift up to 100 lbs.
• Ability to stand in steel-toed shoes for a minimum of 7 hrs. 

EDUCATION AND EXPERIENCE

Basic Qualifications:

• High school diploma or equivalent.
• 4-5 years of experience in a pharmaceutical operation.

Preferred Qualifications:

• Associate degree or higher in science/technical discipline
• 4-5 years of experience in a sterile pharmaceutical operation.