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Laboratory Production Technician
2 months ago
About Meridian Bioscience:
Meridian Bioscience is a comprehensive life science organization that specializes in the development, manufacturing, marketing, and distribution of a diverse array of innovative diagnostic solutions.
Our commitment lies in creating and providing superior solutions that deliver rapid, precise, and straightforward answers, redefining the landscape of life from discovery to diagnosis.
We seek enthusiastic and skilled individuals who can contribute to our vision. Our progressive culture fosters collaboration, enabling candidates to innovate and devise cutting-edge solutions to complex challenges.Position Overview:
The Laboratory Production Technician role involves executing designated manufacturing and laboratory support tasks in accordance with company protocols, standard operating procedures (SOPs), and quality standards.
This role encompasses performing both upstream and downstream bioprocessing operations to facilitate the commercial production of native antigens, recombinant proteins, antibodies, and blockers.
Upstream processes include tissue culture, cell bioreactors, fermentation, virus propagation, cell and virus bank production, as well as buffer/media preparation. Downstream operations consist of harvest, clarification, chromatography, centrifugation, TFF (UF/DF), filtration, formulation, and fill-finish. The individual will be responsible for maintaining a designated laboratory area and executing equipment and laboratory cleaning protocols.The candidate must be adept at executing assigned procedures in a dynamic and results-driven environment while adhering to quality standards aligned with customer satisfaction, cost efficiency, scheduling, and ISO13485 regulations.
Key Responsibilities:
Essential Tasks:
- Collaborate with supervisors or managers to coordinate daily production activities, ensuring alignment with the production timeline. Independently complete daily tasks in accordance with relevant manufacturing documents, SOPs, and regulations.
- Access controlled documents from document management software, review procedures, confirm adequate training, and ensure sufficient inventory of equipment, reagents, and materials before commencing manufacturing tasks.
- Monitor and request or initiate in-house production of raw materials and supplies necessary to meet production timelines.
- Ensure the proper usage, cleaning, sanitization, maintenance, validation, calibration, and certification of required equipment as necessary.
- Grasp and implement the principles of aseptic technique.
- Generate and document all data and observations as required, completing all necessary calculations in compliance with company policies.
- Promptly inform supervisors or managers of any deviations from established production documents or SOPs.
- Maintain accurate data sheets, records, and logs in accordance with SOPs, OSHA requirements, and quality system standards.
- Conduct daily audits of personal paperwork for corrections, omissions, and incomplete information.
- Carry out routine laboratory maintenance and management, including ordering materials, cleaning and maintaining laboratory equipment, tidying the lab area, conducting environmental monitoring, and completing necessary documentation.
- Assist, as needed, in investigations related to product or process nonconformances, including deviations, out-of-specification results, corrective and preventive actions, or complaints.
- Participate in procedure reviews and document improvement processes.
- Troubleshoot and address any identified issues with resources, scheduling, procedures, or product quality, collaborating with relevant departments, supervisors, or managers to meet company objectives.
- Complete all assigned training independently and respond to daily company communications as required.
Primary work requirements include operating in a regulated bioprocessing environment.
Ability to navigate multiple flights of stairs throughout the workday in a multi-location facility.
Must be capable of routinely lifting up to 40 lbs. during the work shift.
Must be able to wear personal protective equipment (face coverings, gloves, lab coats, etc.).
Ability to stand and sit for extended periods, bend, reach, and maneuver carts throughout the work shift.
May be required to work outside of standard business hours, including evenings and/or weekends, to support business needs.
Must adhere to applicable biosafety and chemical hygiene practices while on the manufacturing floor or in laboratories.
Qualifications:
- A Bachelor's or Master's degree from an accredited institution in a relevant scientific field such as Chemistry, Biology, Biochemistry, Molecular Biology, or Protein Chemistry is preferred.
- An Associate's degree or High School diploma/GED with a minimum of 3 years of bioprocessing experience in a GMP environment is the minimum requirement.
- Previous experience in manufacturing or assembly within a quality-regulated setting is advantageous.
- Prior experience operating bioreactors, fermenters, FPLC systems, and TFF systems is desirable.
- Key Stakeholders
o This position will collaborate with manufacturing, quality assurance, materials management, technical operations, and other departments as necessary to complete assigned tasks.
- Line Management
o This role is an independent contributor.
o The position does not have any direct reports.
*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.