Manufacturing Specialist II

Company: eTeam Inc.
Location: Austin
Posted on: January 25, 2023

Job Description:

Schedule: -4-3-3-4 schedules, -6 pm-6 am, Sun-Tues and every other Saturday

Position Summary
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 pumps.
--- 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 rules.
--- 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 documents.
--- 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 qualification testing.
--- 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 Specialist.

Work Environment
--- 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 environment.
--- Work in manufacturing area and clean room environment.
--- Must be able to wear required gowning garments, including a respirator.
--- Lift pre-filter tops and final filter housings up to 50 lbs. unassisted.
--- 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 shift.
--- 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