JOB PURPOSE

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.

KEY ACCOUNTABILITIES

Maintains curriculum gowning qualifications. Ability to perform all job duties using acceptable aseptic technique. Sets up & operates automated filling and support equipment such as fillers, stoppering units and cappers. Completes applicable paperwork and log book entries for the filling rooms in accordance with approved procedures. Follows all written procedures for operation of the fill room. Performs clean-up of equipment and room, including walls and floor, as necessary. Collects samples, performs fill weight checks and other quality checks as necessary. Assists with or performs preventive maintenance tasks on filling equipment, such as inspection and cleaning of machine parts, as may be required. Refers process issues to Supervisor or designee. Informs supervisor of maintenance and/or safety issues. Works overtime with short notice when production requires. Performs all other duties as determined by supervisor and management.

QUALIFICATIONS

Minimum: High School diploma or equivalent.

EXPERIENCE

Minimum: 1 year experience operating production equipment and /or operating analytical instrumentation or 2 (two) years as a Clean Room Operator required. Prior aseptic technique training preferred but not required. 

SKILLS

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.

What We Offer

Clean climate-controlled working environment Annual performance bonus potential 401k employer match up to 6% of your contributions 23 vacation/personal days 11 paid Company holidays Generous healthcare benefits Employee discount program Wellbeing rewards programs Safety and Quality is a top organizational priority Career advancement/growth opportunities Tuition Reimbursement Maternity and Parental Leave

 

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.