Operator I, Manufacturing (Lyophilization 1st Shift)
Job ID :
US - Virginia - Middletown
- Works alone or with other technicians to perform filling, labeling and/or packaging of products.
- Comply with GMP, ISO 13485 guidelines and company SOPs.
- Must be able to comprehend production paper work up to and including product reconciliation, label reconciliation, labor sheets, product fill checks, torque checks, etc.
- Cleans and sanitizes work areas, machines, glassware or equipment as needed or directed, if required in work area.
- Operates and/or monitors production equipment and makes necessary adjustments to ensure smooth operations and high quality results, if required in work area.
- Must be able to interface and communicate effectively with work groups to ensure completion of tasks and projects.
- Must be able to work in a fast paced environment with changing priorities.
- Performs other duties as assigned.
- High school diploma or equivalent from an accredited institution
- One year related experience and/or training; or equivalent combination of education and experience in manufacturing.
- Ability to perform the duties of this job by regularly being required to stand; walk; use hands to finger, handle or feel objects, tools or controls; talk and hear; and smell.
- Ability to frequently reach with hands and arms and stoop, kneel, crouch, or crawl.
- Ability to sit for extended period of time depending on the nature of the work.
- Ability to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Employee to employ traditional lifting techniques for materials up to 75 lbs. Items over 75 lbs will require the employee to use non traditional techniques including, push-pull method, automated lifts and other equipment or additional techniques. Employee will be trained in these techniques upon employment.
- Vision abilities required by this job include close vision, distance vision, color vision and the ability to adjust focus.
- Ability to be frequently exposed to wet conditions and work in extreme cold.
- Frequently exposed to strong and sometimes disagreeable odors and occasionally exposed to toxic or caustic chemicals.
- Ability to occasionally work near moving mechanical parts.
- Ability to work in a moderate noise level.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Ability to understand and carry out instructions furnished in written, oral or diagram form.
- Ability to deal with problems involving several concrete variables in standardized situations.
- Ability to handle multiple tasks and react appropriately to changing priorities and impending deadlines.
- Knowledge of GMP, FDA, ISO Regulations for diagnostics manufacturing.
- Knowledge of handling hazardous materials, OSHA safety compliance required.