Manufacturing Technician

Validation & Engineering Group; United States; On-site; USD 42,000 - 58,000; Full time

Benefits offered by this job

Cleanroom environment

Job summary

Validation & Engineering Group is seeking Manufacturing Technicians to support production operations for a medical device manufacturing facility in Austin, Texas. The role involves hands-on work in a controlled cleanroom environment, following SOPs, GDP and ISO 13485 aligned quality procedures to assist embolic device production.

Ideal candidates have experience in regulated manufacturing environments with strong attention to detail and the ability to document production activities accurately.

Qualifications

• High school diploma or equivalent required; technical degree or relevant training is a plus.
• Experience in medical device/pharma/biotech or other regulated manufacturing environments preferred.
• Strong attention to detail and ability to perform repetitive precision tasks.
• Familiarity with GMP/GDP ISO 13485 FDA regulations or other regulated manufacturing requirements preferred.

Responsibilities

• Perform hands on manufacturing and production activities in a controlled cleanroom environment.
• Follow established manufacturing procedures, work instructions, SOPs and safety requirements.
• Complete production and batch documentation accurately and in accordance with GDP.
• Maintain cleanroom standards, gowning, hygiene, contamination control and housekeeping.

Skills

Attention to detail

Manual dexterity

Procedural compliance

PPE and cleanroom discipline

Education

High school diploma or equivalent

Technical degree or relevant training

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 Manufacturing Technicians 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 Medical device manufacturing Pharmaceutical manufacturing Biopharmaceutical manufacturing Chemical processing Cleanroom production Precision manufacturing Laboratory production Batch manufacturing GMPGDP 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 youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its 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