Pharmaceutical Operator I

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

SUMMARY OF POSITION:

This position is responsible for operating large scale manufacturing equipment to produce bulk APIs (Active Pharmaceutical Ingredients) in accordance with Company standards and operating procedures. He/she will be responsible for reports and documentation. Must be able to pay attention to detail due to the nature of chemicals and environment he/she will be working in on a daily basis.

ESSENTIAL FUNCTIONS:

• Operates in a regulated environment and complies with all cGMP and OSHA regulations applicable to manufacturing responsibilities. This includes understanding and following all applicable batch records, standard operating procedures and work instructions, and wearing appropriate personal protective equipment (PPE)
• Operates and monitors reaction vessels, crystallizers, centrifuges, filters, evaporator, heat exchangers, pumps, valves and other equipment through manual operations, panel boards, indicators, and HMI displays (for PLC and DCS controls) following applicable batch records, procedures, and good documentation practices.
• Operates and monitors hoists, dryers, mills, sifters, dust collectors, blowers, packaging stations, and other equipment through manual operations, panel boards, indicators, and HMI displays (for PLC controls) following applicable batch records, procedures, and good documentation practices.
• Packages, weighs, samples, and labels finished goods and intermediate products following applicable batch records, procedures, and good documentation practices.
• Maintains detailed operating reports and batch records, including notes on problems and records on added weights, volumes, measured temperatures, pH levels, pressures, and flow rates following applicable procedures and as directed by supervisor.
• Operates forklifts, hoists, and other material handling devices to move bulk raw materials, WIP, and packaged goods to and from pick-up points.
• Delivers samples to laboratory and retrieves operating supplies from storerooms.
• Monitors environmental and safety devices (scrubber, rupture discs, relief valves, etc.) to ensure that the equipment is functioning properly.
• Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures.
• Participates in various employee involvement teams and committees, such as Area/Site Safety Teams, Kaizen events, and Cost Savings Teams, to improve the workplace, increase efficiency, and maximize productivity.
• Performs Lock Out/Tag Out (LOTO) independently using personal lock.
• Other duties as assigned by Management.

SKILL LEVEL:

• Has a basic understanding of equipment and processes in their area of responsibility.
• Can perform basic troubleshooting of equipment or process malfunctions in their area of responsibility.
• Exercises judgment within defined procedures and practices to determine appropriate actions.

MINIMUM REQUIREMENTS:

Education:

High School Diploma, GED, or equivalent required

Previous GMP manufacturing experience preferred

Experience:

Previous experience in a GMP manufacturing environment (preferred)

Preferred Skills/Qualifications:

Must be able to communicate effectively in both verbal and written formats.

Must be able to read and follow detailed instructions and procedures.

Must be able to perform basic math.

Must have a working knowledge of chemical and/or powder processing equipment and associated safety requirements.

TYPICAL DEMONSTRATED PROFICIENCIES:

• Works toward qualification in either all APAP Wet End operations or all APAP Drying Tower operations.

LEADERSHIP RESPONSIBILITIES:

• No direct responsibility for the work of others
• Normally receives general instructions on routine work and detailed instructions on new assignments.

• Must possess sound problem solving and decision-making skills.

  Must work in a team environment to perform job tasks and cover workstations during breaks and lunches

RELATIONSHIP WITH OTHERS/ SCOPE:

• Reports to APAP Shift Supervisor in the APAP production department
• No positions report directly to the APAP Pharmaceutical Operator I
• Has frequent contact with: APAP production personnel, Quality (QA/QC), Safety and Maintenance

WORKING CONDITIONS:

• Must be able to wear required Personal Protective Equipment (PPE), including hard hat, safety glasses, ear plugs, steel-toe boots, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary.
• Must be able to lift and carry up to 50 pounds. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used, when possible, but use of proper lifting and movement techniques is necessary to prevent injury.
• Must be physically able to climb stairs and ladders, roll drums, lift and pour bags of raw materials, drive forklifts, etc.
• Must be able to work in outdoor conditions as portions of the facility are not climate controlled.
• Must be able to work rotating 12-hour shifts and overtime as needed.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.