Manufacturing Specialist

6month initial contract

OVERNIGHT SHIFT 6PM-6AM

4,3,3,4 Schedule (4 days on, 3 days off, 3 days on, 4 days off)

Austin, TX

Orion Group is hiring a Manufacturing Specialist to join our intravenous medical device manufacturing company in Austin, TX.

Manufacturing Specialist Position Summary:

The Manufacturing Specialist will set up and operate production equipment to prepare intravenous and irrigation solutions utilizing established guidelines (SOPs, batch records, safety procedures, etc.).

The Manufacturing Specialist will calculate and record data in official plant documents.

The Manufacturing Specialist will comply with plant rules and regulations pertaining to cGMP, Safety and Personnel related matters.

Manufacturing Specialist 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.

Manufacturing Specialist Qualifications:

• 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.

Manufacturing Specialist 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.

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

Job Types: Full-time, Contract, Temporary

Pay: $17.00 - $19.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• Quantity Sufficient procedures: 1 year (Preferred)
• CGMP guidelines: 1 year (Preferred)
• Reading SOPs: 1 year (Preferred)
• Reading Equipment Drawing: 1 year (Preferred)
• Above Average Mathematical skills: 1 year (Preferred)
• Filter Integrity Testing: 1 year (Preferred)
• Dual Batch process: 1 year (Preferred)
• Materials handling: 1 year (Preferred)
• pH Testing: 1 year (Preferred)
• Troubleshoot equipment: 1 year (Preferred)
• Manufacturing: 1 year (Required)

Work Location: One location

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