Manufacturing Operator

Job Title:

Manufacturing Operator III

Job Grade:

OH

Department:

Manufacturing

FLSA Classification:

Non-Exempt

Manager’s Job Title:

Supervisor or Manager, Production

Department Head Title:

Director, Production Operations

Does This Position Have Any Direct Reports?

No

Job Description Approval Date:

May 6, 2021

Job Summary

Performs functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP).  Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards.

Area Of Responsibility

• Under limited Supervision:
  • • Operate equipment for two or more production processes: Glatt fluid bed processor, Granulation, Blending, Compression Coating, Imprinting, Banding and Encapsulation.
    • Perform machine changeovers, cleaning, & set up as required.

• • • Troubleshoot and make appropriate adjustments to maintain production specifications.
• Ensure adherence to quality standards during the manufacturing process.
• Complete manufacturing documents, ensuring accuracy and completeness.
• Maintain compliance at all times with appropriate SOP’s and cGMP’s.
• Perform duties through proper, safe use of equipment following all OSHA regulations and Equipment Manuals.
• Train or coach entry level Operators.
• May act as Team Lead in their absence.

Work Conditions:

Environmental related to manufacturing/production environments:

• Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
• Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
• Odors: Unpleasant smells.
• Gases: Examples include carbon monoxide and ozone.
• Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
• Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives,  toxic chemicals, and electric shock.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to use hands to handle and feel and talk and hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
• Must be capable of bending and lifting, moving and/or carrying up to 50 pounds.
• Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
• Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Travel Estimate

Up to     0   %

Education and Job Qualification

• High School/Trade School/Vocational School Diploma, GED, or equivalent
• Forklift or other related equipment certification required
• Excellent Troubleshooting skills
• Solid knowledge of cGMP and other pharmaceutical regulatory requirements
• Solid knowledge of Occupational Health & Safety procedures
• Strong Math and Computer Skills including MS Office and SAP
• Strong Interpersonal & communication (both verbal & written) skills
• The requirement for English language proficiency for this job role elementary 1 (comparable to CEFR basic A2) level based on the Common European Framework of Reference for Languages (CEFR).

Experience

• Minimum five (5) years of Production/Manufacturing experience including minimum of 3 years of experience in primary production process and minimum of two years in a secondary process.