Using company guidelines, the Filling Operator I is responsible for the full spectrum of duties in controlled filling and ancillary rooms. This may include but is not limited to: set-up, operation, sanitization, equipment cleaning, PM activities, airlock and ancillary room cleaning, etc.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education Requirements:
High School diploma or equivalent.
Experience Requirements:
Requires a minimum of 1 (one) year experience operating production equipment and /or operating analytical instrumentation or 2 (two) years as a Clean Room Operator. Prior aseptic technique training preferred but not required.
Language Skills:
Good oral and written communication skills are essential. Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs.
Mathematical Skills:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Ability to examine problem areas and make recommendations for corrective action. Must be able to comprehend and follow all applicable SOPs.
Physical Demands:
Must be able to lift 15 lbs. Must be able to stand for long periods of time.
The cleaning function of the position requires frequent bending, twisting, pushing, pulling and lifting.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment:
Filling Operator I must work in filling suites totally gowned with mask, hood, coverall and gloves. At times environment can be confining. The noise level is moderate to loud. Use of hearing protection may be required. The use of sanitizing agents to clean the filling room may be moderately disagreeable.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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