General Purpose of Position:
Responsible for the setup, operation, cleaning, and routine maintenance of pharmaceutical manufacturing and packaging equipment, as well as the associated production rooms.  Operating as part of a team, this position follows SOPs (standard operating procedures); adheres to Quality, Safety and Environmental standards; meets production and product development targets; communicates with supervisors, engineers / scientists, QA (Quality Assurance) and other operators; assists with troubleshooting; engages in process improvement initiatives and works collaboratively with the manufacturing team and all other departments. 
 
Primary Duties and Responsibilities (Essential Functions):
 

	Duties/Responsibilities
1	Ensure the product is being manufactured with strict adherence to all processing, Quality, Safety and Environmental SOPs, batch records, guidelines, and policies
2	Set up, operate, monitor, clean, and maintain various processing, packaging and testing equipment, as well as their associated rooms
3	Assist in certain maintenance activities to ensure repairs, routine preventative maintenance, and calibrations are performed in a timely manner with minimal impact on processing schedules and complete adherence to procedures and Quality, Safety and Environmental guidelines
4	Ensure appropriate actions are taken in the event of deviations and emergencies
5	Ensure that batch records and all associated process documentation are completed as they occur and done right the first time by utilizing manufacturing and documentation policies and procedures
6	Continuously evaluate processes with regard to quality, safety, environmental, and productivity enhancements
7	Maintain good housekeeping within their work area
8	Notify supervisor of any issues that can negatively impact compliance, safety, or productivity
9	Assist other departments when reasonable and necessary tasks are required for compliance, efficiency, etc.
10	Communicate batch / equipment status and issues to supervisor and other operators.  Actively participate in shift change meetings.
11	Participate in problem solving sessions, investigations and process improvement initiatives
12	Train in all areas (primary packaging, 3DP (three dimensional printing), and compounding)  in order to successfully rotate between the functional duties and support changing production needs
13	Actively participate on trial, transfer, and validation batches, supporting the expansion of the Production and 3D printer areas.
14	Keep current on all required training
15	Assist with project work during downtime between production campaigns

 
Reporting to this Position:
No direct reports
 
Travel:
None
 
Work Shift:
Responsibilities for this role may be covered across multiple shifts and include weekends, holidays, evenings, and 24-hour emergency on-call.   This position consists of a 4 10 hour day week Monday –Thursday with overtime expected.
 
Knowledge, Skills and Abilities:

• Demonstrated success working in a team environment
• Knowledge of process control techniques, maintenance procedures, and safe work practices related to equipment operation and chemical handling
• Knowledge of cGMPs (current Good Manufacturing Practices) essential
• Strong problem-solving and critical thinking skills
• Good computer and math skills required in order to reconcile and analyze production data
• Good oral and written communication skills required
• Ability to contribute to the development and updating of production batch records and SOPs required
• Ability to participate in the investigation of non-conformance reports is required
• Ability to lead by example and be a part of a team

Education and Experience:

• Operator I - High School diploma or general education degree (GED) is required. Some experience working with pharmaceutical solid dose manufacturing equipment and processes helpful.
• Operator II - High School diploma or general education degree (GED) is required. 2-5 years experience working with pharmaceutical solid dose manufacturing equipment and processes.
• Operator III - High School diploma or general education degree (GED) is required. Five plus years experience working with pharmaceutical solid dose manufacturing equipment and processes preferred.

Physical Demands and Work Environment:    

• Ability to stand for extended periods of time
• Ability to lift and maneuver up to 50 pounds
• Awkward body positions (kneeling, bending, reaching) while performing work responsibilities
• Ability to wear PPE (personal protective equipment) such as respirators, gloves, etc. for an extended period of time

 
GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies.  The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.  It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.  The position may require other duties as assigned and can be changed at any time by the company.
 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.