Manufacturing Operator I

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 Extensive Supervision:

• • • Operate equipment for one production process 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.

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

• Minimum of High School/Trade School/Vocational School Diploma, GED, or equivalent.
• Forklift or other related equipment certification preferred.
• Basic Troubleshooting skills.
• Basic knowledge of cGMP and other pharmaceutical regulatory requirements.
• Basic knowledge of Occupational Health & Safety procedures.
• Good Math and Computer Skills including MS Office and some experience with SAP preferred.
• Good Interpersonal skills.
• Good communication skills.
• The requirement for English language proficiency for this job role is Basic – A2 (comparable to Global CEFR Basic A2) level based on the Common European Framework of Reference for Languages (CEFR).

Experience

• Entry level position, previous experience not required.