Pharmaceutical Operator I

Job Title

Pharmaceutical Operator I

Requisition

JR000015260 Pharmaceutical Operator I (Open)

Location

Raleigh, NC

Additional Locations

Job Description Summary

This position is responsible for operating large scale manufacturing equipment to produce bulk organic chemicals 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.

Job Description

ESSENTIAL FUNCTIONS:

• Operates in a regulated environment and complies with all cGMP and OSHA regulations applicable to manufacturing responsibilities.  This includes wearing appropriate personnel protection equipment (PPE), understanding and following all applicable standard operating procedures, work instructions, and standard work practices applicable to job responsibilities
• Operates and monitors dryers, mills, sifters, dust collectors, blowers, packaging stations, and other miscellaneous equipment through manual operations, panel boards, indicators, PLC displays, and DCS screens following applicable batch records, procedures and good documentation practices
• Packages, weighs, samples, and labels finished and intermediate products following applicable procedures and good manufacturing 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
• Delivers samples to laboratory and retrieves operating supplies from storeroom
• Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures.
• Other duties as assigned by Management

  DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Monitors environmental and safety devices (scrubbers, ruptured discs, etc.) to insure that the equipment is functioning properly.
• Performs Lock Out/Tag Out (LOTO) independently.
• Operates fork lifts, hoists, and other material handling devices to physically move bulk raw materials, WIP, and packaged goods to and from pick-up points
• 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 improve productivity

  MINIMUM REQUIREMENTS:

Education:

High School Diploma, GED, or equivalent required.

Associate or Technical degree preferred.

Experience:

Previous GMP/ISO manufacturing experience preferred

Skills/Qualifications:

Skills/Competencies:

Other Skills:

Must be able to read and follow detailed instructions and procedures, and effectively communicate in both verbal and written formats.

Must be able to perform basic math.

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

Possess sound decision making skills.

Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams

Must work in a team environment to cover work stations during breaks and lunches

Must be able to wear the required Personal Protective Equipment (PPE) required for the job or task. 

Sound decision making skills.

Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams

RELATIONSHIP WITH OTHERS/ SCOPE:

• Performs diversified duties following standard procedures and under the direction of a production supervisor or lead operator.  Requires a high level of safety awareness and ability to determine when equipment is not performing to standards or expectations.
• Responsible for proper operation of processing equipment to ensure optimum production of high quality products.  Mistakes and errors normally result in unacceptable product and or mechanical equipment damage.  As a result, impacts our product status in the market place.
• Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed.
• No direct responsibility for the work of others; however, the team approach is emphasized in order to cover work stations during breaks and lunches.  Furthermore, the “buddy system” for training new operators creates additional responsibility. 

  WORKING CONDITIONS:

• Must be able to wear the required Personal Protective Equipment (PPE), including  full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel–toed shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate, or safety guidelines.
• An open-air construction exposes operators to the normal year-round outside climate.  Some relief from the elements is available in the control rooms and break area.
• Dirty conditions and chemical fumes can be present in the work areas.
• Must be able to lift and carry up to 50 pounds.  Material handling devices (e.g., hand truck, for truck, and conveyors) are used when possible but use of proper lifting and movement techniques is necessary to prevent injury.
• Must be able to physically climb stairs and evacuation ladders, rolling drums, lifting and pouring bags of raw materials, driving forklifts, climbing and entering reaction vessels and perform first aid.
• Must be able to work rotating 12 hours/day shift and occasional 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.