Medical Device Manufacturing Technician — Cleanroom

Veg Group; Austin (TX); Híbrido; USD 42 000 - 64 000; Tempo integral

Resumo da oferta

Validation & Engineering Group, Inc. in Austin, TX is seeking Manufacturing Technicians to support production of embolic medical devices in a controlled cleanroom environment.

Candidates will follow GMP/GDP, ISO 13485 and FDA requirements, perform precise weighing and material handling, and maintain accurate batch documentation. Experience in regulated manufacturing preferred; high school diploma required with technical training a plus.

Qualificações

• High school diploma or equivalent required; technical degree or relevant training is a plus.
• Previous experience in medical device, pharmaceutical, biotech, chemical manufacturing environments preferred.
• Experience working in a cleanroom or controlled manufacturing environment strongly preferred.
• Ability to follow detailed procedures and work instructions consistently.
• Strong attention to detail and ability to perform repetitive, precision-oriented tasks.
• Comfortable working with chemicals and wearing appropriate PPE.
• Ability to weigh, measure, dispense, and document materials.
• Strong manual dexterity and hand-eye coordination.
• Ability to complete manufacturing documentation accurately and in a timely manner.
• Familiarity with GMP, GDP, ISO 13485, FDA regulations, or other regulated manufacturing requirements is preferred.
• Ability to work onsite in Austin, Texas.

Responsabilidades

• Perform hands-on manufacturing and production activities in a controlled cleanroom environment.
• Follow established manufacturing procedures, work instructions, SOPs, and safety requirements.
• Perform precise weighing, measuring, dispensing, mixing, and handling of materials.
• Support chemical processing activities, including bead formation, crosslinking, coating, washing, and other process steps.
• Perform sieving and particle-size classification activities according to established specifications.
• Support product suspension, filling, sealing, and packaging operations.
• Perform detailed manual assembly and processing activities requiring strong attention to detail and fine motor skills.
• Complete production and batch documentation accurately and in accordance with GDP.
• Follow applicable quality systems, including ISO 13485 and FDA 21 CFR requirements.
• Perform in-process inspections and support quality control activities, including particle-size and other product testing.
• Maintain cleanroom standards, including proper gowning, hygiene, contamination control, and housekeeping.
• Safely handle chemicals and production materials using required PPE and established safety procedures.
• Identify and report deviations, abnormalities, equipment issues, or quality concerns to appropriate personnel.
• Work effectively with Manufacturing, Quality, Engineering, and other cross-functional teams.
• Maintain a safe, organized, and compliant production environment.

Conhecimentos

Attention to detail

Manual dexterity

Following detailed procedures

Formação académica

High school diploma or equivalent

Technical degree or relevant training

Descrição da oferta de emprego

Validation & Engineering Group, Inc. in Austin, TX is seeking Manufacturing Technicians to support production of embolic medical devices in a controlled cleanroom environment.

Candidates will follow GMP/GDP, ISO 13485 and FDA requirements, perform precise weighing and material handling, and maintain accurate batch documentation. Experience in regulated manufacturing preferred; high school diploma required with technical training a plus.