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Position Summary & Responsibilities:

The normal working hours for this role are Sunday - Thursday from 2:00pm - 10:30pm.

The Senior Technician is a production support position in Media Production with a primary responsibility of planning and executing the production of long term antibiotic stocks, base broths, and other reagents. Secondary functions include periodically assisting in the production of Vitek susceptibility and identification media, providing expert guidance to Media Technicians on technical topics and production activities associated with AMDS. Tertiary functions include providing on-the-job training to incoming Media Technicians, scheduling of products in MES and SAP, as well as undertaking other projects as needed.

+ Perform all work in the Production Department in a safe manner in accordance with the company policy and/or procedure.

+ Maintain FEFO for all long-term stocks, broths and chemical components.

+ Perform and document all manufacturing steps and verification as described in company procedures/policies for the following, but not limited to:

+ Ensure Media and/or sub component preparation is completed in a timely manner for prompt product delivery to pour station based on production schedule.

+ Filtrations – including checks to ensure that correct filters are used according to policy/procedure

+ Verify that all media and chemicals are appropriately labeled and stored based on all regulatory and Master Formulary specifications

+ Perform daily equipment operation including kettles, scales, ph Meters, stir plates, mixers, autoclaves, Steris washers, and Clean-In-Place (CIP) operation

+ Calibrations, daily maintenance, and cleaning of instruments, scales and meters as needed

+ Media dispense setup (verifying the pump dispense volume, placing the dispense head and verifying connections and bag numbering to avoid switched wells, perform pump and dispense head verifications in MES)

+ Maintain chemical and equipment log books; retain records according to departmental procedures.

+ Provide expert knowledge of departmental procedures and consistently uphold all company policies. Ensure that all procedures reflect the current methods used by teammates. Develop and write new procedures as needed.

+ Report scheduling or availability issues with product planned for manufacture in MES to management or scheduler.

+ Provide expert guidance with end of lot documentation review for Device History Record - Master Formulary and Long Term Antibiotic Stock or Reagent Master Formularies. This includes but is not limited to the following:

+ Generate any needed Formularies or documentation from the office PC, Livelink, or MES as needed for production

+ Accuracy and verification checks - Operator/Observer signatures, data accuracy, all pages present

+ Supporting documentation – weigh tapes, pH meter tapes, MES reports, waivers, etc.

+ Participate in new product development, re-development of existing products, and assist with new product transition to production from R&D and Industrialization as required.

+ Attend periodic interdepartmental meetings to represent the needs of the department.

+ Reasonable, reliable attendance and punctuality is an essential job function required for this position.

+ Perform other duties and projects related to lab and department operations as requested by management.

Education, Skills, & Experience:

+ Bachelor of Science degree in Biology/Chemistry with one (1) year wet chemistry and/or bench work experience required.

+ Associates degree with 3+ years wet chemistry and/or bench work also accepted

+ High School Diploma/GED with 5+ years wet chemistry and/or bench work also accepted

+ Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands. Excellent problem solving, time management and laboratory skills.

+ Ability to work independently and in groups.

+ Ability to effectively train other team members.

+ Adapt well to frequent changes to expectations, priorities, and production demands; must be accepting of changing methods to align with new information, changing conditions and unexpected obstacles.

+ Knowledge of sterile techniques and general laboratory procedures.

+ Working knowledge of GLP/GMP and ISO guidelines.

+ Strong PC skills (Microsoft Office Suite, SAP desired).

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