Manufacturing Operator III

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.

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.

• 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.

• 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.

• 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.

Up to 0 %

• 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).

• 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.

The presently-anticipated base compensation pay range for this position is $25.00/hr to $32.00/hr actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage;

life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time,…