Manufacturing Technician

Pinnaql, Inc.; Austin (TX); Hybrid; USD 42,000 - 62,000; Full time

Job summary

Validation & Engineering Group, Inc. in Austin, TX seeks Manufacturing Technicians to support production of embolic medical devices in a cleanroom. Candidates should have experience in regulated environments and the ability to perform precise, hands-on manufacturing while adhering to safety and quality procedures.

Role emphasizes detailed documentation, batch records, and strong attention to cleanliness; onsite work in Austin is required, with GMP/GDP and ISO 13485 compliance expectations.

Qualifications

• Must have high attention to detail in repetitive precision tasks.
• Experience in cleanroom or controlled manufacturing environments preferred.
• Ability to weigh, measure, dispense and document materials accurately.
• Strong understanding of GDP, GMP, ISO 13485 and FDA requirements is a plus.

Responsibilities

• Perform hands-on manufacturing in a controlled cleanroom environment.
• Follow SOPs, work Instructions, and safety requirements.
• Weigh, measure, dispense, mix and handle materials with precision.
• Support chemical processing steps like bead formation, crosslinking, washing, and coating.
• Document production activities accurately per GDP.

Skills

Attention to detail

Manual dexterity

Data/documentation

Team collaboration

Education

High school diploma or equivalent

Technical training or certificate (preferred)

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

We are seeking Manufacturing Technicians to support production operations for a medical device manufacturing facility in Austin, Texas. The technicians will work in a controlled cleanroom environment supporting the production of embolic medical devices, including microsphere-based products used in interventional procedures.

The ideal candidates will have experience in medical device, pharmaceutical, biotech, chemical manufacturing, or other highly regulated production environments and be comfortable performing detailed, hands‑on manufacturing activities while following strict quality and safety procedures.

Key Responsibilities

• 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 Good Documentation Practices (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.

Qualifications

• High school diploma or equivalent required; technical degree or relevant training is a plus.
• Previous experience in medical device, pharmaceutical, biotech, chemical, laboratory, or other regulated 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 accurately 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.

Preferred Experience

Candidates with experience in any of the following environments are encouraged to apply:

• Pharmaceutical manufacturing
• Biopharmaceutical manufacturing
• Chemical processing
• Cleanroom production
• Precision manufacturing
• Laboratory production
• Batch manufacturing
• GMP/GDP-regulated environments
• Manufacturing documentation and batch records
• Particle sizing, sieving, filtration, or similar processes

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose‑driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.