Manufacturing Specialist II
Company: eTeam Inc.
Posted on: January 25, 2023
Schedule: -4-3-3-4 schedules, -6 pm-6 am, Sun-Tues and every
Set up and operate production equipment to prepare intravenous and
irrigation solutions utilizing established guidelines (SOPs, batch
records, safety procedures, etc.). Calculate and record data in
official plant documents. Comply with plant rules and regulations
pertaining to cGMP, Safety and Personnel related matters.
Essential Duties & Responsibilities
--- Set up, control, and operate production equipment used to
prepare solution batches according to defined procedures. Make
proper and necessary u-bend connections on all u-bends and tank
--- Accurately weigh and check weigh drugs according to specific
bath record / SOP instructions.
--- Perform quantity sufficient (Q.S.) procedures on all lines.
--- Sanitize/clean all equipment and area according to specific
guidelines and SOPs
--- Perform cleaning, inspection, assembly and disassembly of
filters and bubble point (filter integrity) testing.
--- Perform Dual Batch process which involves complex calculations
and specific procedures that ensure the homogeneity of a batch made
using two tanks.
--- Transfer heavy materials/commodities by hand or utilizing
material handling equipment (forklift, etc.)
--- Perform chemical testing of water used for mixing solutions and
equipment rinsing. Make pH or Potentiometric determinations
--- Must identify and troubleshoot equipment problems.
--- Adhere to cGMP guidelines, SOPs and plant policies and
--- Communicate between shifts and support teams. Set the example,
consistent with Company policies and practices so that others may
learn and follow. Is positive and receptive to change. Assists in
the training of new employees.
--- Anticipates operational and personnel problems and acts to
minimize potential negative impact.
--- Assists and supports area improvements, cost reductions,
department changes and attends meetings.
--- Perform other related duties as assigned or required.
Knowledge & Skills
--- Ability to read and comprehend SOPs, batch records and other
--- Able to read and understand equipment drawings.
--- Above average mathematical skills.
--- Must be able to obtain a forklift license, which requires
completion and passing of a forklift physical, written test, and
operating a forklift safely.
--- Six to nine months on the job training (OJT) prior to
--- Additional training may be extended as required.
--- Must be able to multi-task and be proficient on multiple
product processing lines.
Minimum Qualifications, Education & Experience
--- Must be at least 18 years of age
--- High School Diploma or equivalent is required
--- Prefer eighteen months in-plant experience as a Production
Operator or nine months experience as a Manufacturing
--- Work is performed in a clean room environment
--- Must be able to accurately schedule and coordinate activities
in a complex work environment (tank capacity, tank steaming, filter
steaming, utilities and water availability, rinsing/steaming
solution equipment and fill bays etc.).
--- Must focus mental attention for extended periods in a complex
--- Work in manufacturing area and clean room environment.
--- Must be able to wear required gowning garments, including a
--- Lift pre-filter tops and final filter housings up to 50 lbs.
--- Move/lift container of commodities up to 100 lbs. assisted.
--- Utilize pallet jack (3000 lbs.).
--- Must be able to obtain, clean and manipulate drug containers to
weigh and charge drugs to batching tanks throughout the assigned
--- Must be eligible for the respiratory protection program
(physical examination required).
--- Typically requires travel less than 5% of the time
Keywords: eTeam Inc., Austin , Manufacturing Specialist II, Other , Austin, Texas
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