Operator, Molecular Manufacturing
Meridian Bioscience, Inc.
# of Openings
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.
The Molecular Operator has primary responsibility for dispensing of in-vitro medical diagnostic reagents in accordance with current manufacturing directions, SOPs, GMPs, and QSR to meet or exceed quality specifications on schedule at or below standard costs.
* All general responsibilities for a Molecular Assembler.
* Ability to develop mechanical aptitude in areas of assignment.
* Work independently and assist Assemblers.
* Assist in completion of calibrations and routine process monitoring as needed.
* Monitor and requisition inventory for the purpose of fulfilling production needs as needed.
* Learn how to troubleshoot equipment and automation with the support of Maintenance and OCS.
* Become proficient in using all computer programs necessary for the required department.
* Must be able to work independently as well as collaboratively in a team setting with peers in a cross departmental setting.
* Train other employees as required.
* Other duties as assigned.
* Operate, maintain and clean ISO Classified clean rooms and related equipment in accordance with SOPs.
* Perform routine monitoring/cleaning required in the Clean Rooms and/or other production environments.
* Package dispensed molecular reagents as needed.
* Aid in dispensing of reagents (tip, cap, and label product).
* Conduct in process inspections to assure products meet quality specifications.
* Clean and sterilize glassware and production materials as needed.
* Correctly identify all abnormal components and notify the Group Leader or Supervisor.
* Maintain sufficient inventories of supplies and materials necessary to dispense, tip, and cap diagnostic products.
* Dispense reagents as needed.
* Operate and maintain automated production equipment.
* High school diploma or general education degree (GED) required.
* 2+ years' experience in a FDA or other regulated manufacturing, laboratory environment, cleanroom environment experience is preferred.
* Previous laboratory training and/or medical or science related courses helpful.
* Previous experience operating automated equipment and/or assembly experience is preferred.
Skills, Specialized Knowledge and Abilities:
* Basic computer skills required (Word, Excel).
* Must have basic math skills and be able to perform step by step arithmetic calculations.
* Experience with the Metric System preferred.
* Excellent documentation skills as required by cGMPs on a timely basis.
* Ability to read, understand and follow all company SOPs and guidelines.
* Must be a self-starter, detail oriented, organized, prioritize and balance workloads and timelines and be able to perform under pressure in a fast-paced environment.
* Excellent interpersonal, organizational, written and oral communications skills along with the ability to interact with Manufacturing and Quality.
* Ability to maintain regular attendance and punctuality requirements.
* Must be able to work hours outside of the normal work day (start early, stay late or weekends) to support department activities.
* Must be able to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
* Excellent problem solving and troubleshooting skills.
Requirements (Physical, Mental, Environmental Demands):
* Must be able to work in a tobacco free environment; strongly preferred
* Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility.
* Must have the ability to inspect, analyze and concentrate throughout the course of the work shift.
* Must be able to concentrate and problem solve routinely throughout the course of the work shift.
* Must have fine manual dexterity to ensure precise assembly of medical devices - including the ability to tighten caps in a repetitive manner.
* Must have the ability to lift up to 25-50 pounds of supplies or finished product throughout the work shift.
* Ability to stand and/or sit for long periods, stoop, reach, bend, push and pull carts and hand jacks throughout the course of the work shift.
* Must be able to identify and differentiate color on diagnostic devices or components.
* Must be able to distinguish color changes in device components.
* Must be able to read controls systems screens and written documents throughout the course of the workday.
* Must be able to detect audible alarms.
* Must be able to wear full body gown protective equipment for extended periods of time in a cleanroom environment (coveralls, surgical mask, safety glasses, hairnet, shoe covers).
* Must be able to wear a full-face respirator for extended periods of time.
* Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories.
We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.