Manufacturing Technician II, Compounding (7pm - 7am)
Posted on: January 22, 2023
Job Summary Responsible for compounding high-quality solutions,
semi-solids, and suspensions in accordance with Good Manufacturing
Practices (GMP) and department Standard Operating Procedures (SOP).
Job Details This position is responsible for the following:
- Accurate formulation of products.
- Stage, load, operate, and monitor all equipment for product
- Weighing and mixing chemicals according to specific
- Calibrate, operate, and monitor all formulation-related
equipment (e.g., mixers, scales, meters, etc.).
- Perform operations necessary to adjust the pH of product for
- Clean, steam, and sanitizes all tanks, facilities, equipment
and chemical containers used in the product formulation process in
accordance with current SOPs and cGMPs.
- Accurately complete documents and record production volumes
(batches) in compliance with current GDP standards.
- Assumes other duties and responsibilities, as necessary, within
the Compounding department, in an effort to provide the required
support to ensure adherence to the production schedule. Incumbent
has full authority to make decisions and/or take action that is
required to carry out job duties. Internal requirements include
compliance with ethics, environmental health and safety, financial,
human resources, cGMP procedures, general business policies,
requirements and objectives. The incumbent must be willing to take
temporary assignments as required. Regulated Responsibilities
(including cGMP and EHS) Incumbent is expected to be fully
compliant with all criteria established by governmental agencies,
Ministry of Health, and legislative requirements including, but not
limited to: the FDA, European Community (EC), ISO 13485 - Medical
Devices, European Economic Community Medical Device Directive
(MDD), Canadian Medical Device Regulations (CMDR), OSHA,
Sarbanes-Oxley, EPA, DOT, EEOC, and ADA. Incumbent will work to
ensure that the company is in compliance with all environmental,
health and safety requirements and assure our business practices
enhance the welfare of our customers, employees and the community
in which we operate. Education and Experience: Minimum requirements
for this position are: Education High School Diploma or GED
equivalent. Associates Degree preferred with coursework in the
Sciences. Experience: Technical At least two (2) years related work
experience, preferably in a high-speed production or manufacturing
environment. Experience: Regulatory Experience working in a GMP
regulated environment preferred. Experience: Systems Basic user
knowledge of Microsoft Office, SAP experience preferred.
Experience: Aseptic Experience working in an Aseptic Production
environment preferred. Essential Knowledge, Skills &
- Ability to perform detailed tasks and document activities
completely and accurately.
- Ability to think and plan in a logical sequential order.
- Able to work in a controlled environment that includes surgical
mask and goggles.
- Ability to comply with gowning validation and subsequent
- Ability to work any shift (up to 12-hours) as required
dependent on business needs.
- Capable of standing for long periods of time. Capable of using
hands to feel objects, use tools or controls and reach with hands
- Ability to read, comprehend, write, and communicate effectively
- Ability to carry out detailed written or oral
- Ability to work and communicate with others in a professional
and effective manner, within a team-oriented environment.
- Basic user knowledge and understanding of Windows-based
computer systems such as Microsoft Office, with an ability to learn
other computer-based systems.
- Physically able to continuously stand and walk.
- Physically able to lift up to 40 lbs. for men and 35 lbs. for
- Physically able to bend, climb, lift, squat, stoop, and stretch
to reach frequently. Work Environment
- Frequently works with hot water and steam.
- Frequently walks on slippery or uneven surfaces.
- May handle and transport Hazardous and Non-Hazardous
- May climb stairs or use ladders and work off elevated surfaces
on an occasional basis during each shift.
- Noise level in the work environment is frequently loud but
managed below the acceptable OSHA regulated level. Principal
Accountabilities Percent indicated is the average time spent on a
task and will vary depending on the workflow. % Time Task #
Description of Task 40% 1. Responsible for the compounding
activities of manufacturing solutions, semi-solids, and
suspensions, including weighing, bulking, sterile filtration, steam
sterilization, sanitization, and documentation activities
associated with the manufacturing. Sets up, inspect, and operate
equipment to process sterile solutions. Utilize aseptic techniques
to maintain product sterility. Report process deviations to
supervisor to prevent product deviations. Comply with cGMP rules
and procedures. 25% 2. Maintain, complete, and review all
production documentation including batch records, logbooks,
sterilization records, and weighing documentation. Identifies and
prevents possible sources of non-compliance in the area. Maintains
the manufacturing area housekeeping to current standards. Assists
in performing preventative maintenance activities. 10% 3. Prepares
all equipment for production by performing cleaning and
sanitization duties. Inspects all equipment and facilities prior to
use. Assists in performing preventative maintenance. 10% 4. Ensures
proper accountability of raw materials. Coordinates and ensure all
expired raw materials are removed from the manufacturing areas. 5%
5. Assists in the performance of Compounding and Validation
projects assigned by Department Management. 5% 6. Actively
participate in departmental meetings and contribute to the
achievement of the following Department performance indicators:
*Adherence to the Production Schedule. *Reduction of batch errors
and deviations, *Consistent compliance with cGMPs by avoiding
significant cGMP violations and successful FDA audits with no major
observations. 5% 7. Satisfactory performance in complying with all
safety rules and procedures, effective contribution in identifying
and preventing accidents and unsafe working conditions. Individual
participation in meeting the accident frequency goal. At AbbVie, we
value bringing together individuals from diverse backgrounds to
develop new and innovative solutions for patients. As an equal
opportunity and affirmative action employer, we do not discriminate
on the basis of race, color, religion, national origin, age, sex
(including pregnancy), physical or mental disability, medical
condition, genetic information, gender identity or expression,
sexual orientation, marital status, protected veteran status, or
any other legally protected characteristic. If you would like to
view a copy of the companys affirmative action plan or policy
statement, please email CorpJat_ABV@abbvie.com.
Keywords: AbbVie, Waco , Manufacturing Technician II, Compounding (7pm - 7am), Professions , Waco, Texas
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