Production Technician

Tiger BioSciences; San Antonio (TX); On-site; USD 42,000 - 54,000; Full time

Job summary

Tiger BioSciences in San Antonio, TX is seeking a Production Technician I to support human tissue manufacturing under GMP and FDA regulations. You will perform aseptic processing, document steps, and maintain cleanroom practices to sustain the production schedule.

Responsibilities include completing SOP training, maintaining competency, assisting with equipment cleaning, calibration, environmental monitoring, and accurate record-keeping in controlled records.

Qualifications

• High school diploma or equivalent required.
• At least 1 year hands-on experience with aseptic technique.
• Experience in an FDA-regulated environment preferred.
• Background/clearance check required.

Responsibilities

• Manufacture finished products from human tissue using aseptic technique in compliance with SOPs.
• Complete assigned SOP training by required deadlines.
• Perform cleanroom and equipment cleaning, decontamination, calibration, and environmental monitoring.
• Accurately document manufacturing processes in controlled records.
• Report to work on-site and on schedule, including overtime when required.
• Maintain knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO, cGMP, and internal policies.

Skills

Aseptic technique

Attention to detail

Documentation accuracy

Teamwork

SOP adherence

Regulatory compliance

Microsoft Office

Education

High school diploma or equivalent

Associate's or Bachelor's degree substitute for experience

Tools

Microsoft Office

Job description

Purpose

The Production Technician I is responsible for developing and maintaining proficiency in human tissue manufacturing procedures and related support processes to execute and sustain the production schedule. This role requires strict adherence to FDA regulations, industry standards, and Good Manufacturing Practices (GMP).

Responsibilities

• Complete assigned training on standard operating procedures (SOPs) by required deadlines
• Maintain competency in aseptic technique and sterile field protocols through ongoing training
• Manufacture finished products from human tissue using aseptic technique in compliance with SOPs
• Apply good judgment to optimize tissue processing efficiency and maximize product yield
• Identify and report deviations and nonconformances to management and Quality Assurance
• Perform cleanroom and equipment cleaning, decontamination, calibration, and environmental monitoring
• Decontaminate, wrap, and autoclave reusable manufacturing supplies in accordance with SOPs
• Accurately and concurrently document manufacturing processes and support tasks in controlled records
• Ensure all documentation complies with GDP, SOPs, and regulatory requirements
• Report to work on-site and on time for scheduled shifts, including mandatory overtime when required
• Attend all scheduled meetings, training sessions, and appointments as assigned
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
• Perform other duties as assigned

Skills

• Ability to work independently and in a team environment
• Excellent attention to detail and organization
• Excellent written and verbal communication
• Highest level of ethics and integrity
• Ability to lead and motivate the right behaviors
• Ability to multi-task and work in a fast-paced environment
• Proficient in aseptic technique
• Excellent documentation accuracy
• Proficiency in Microsoft Office
• Ability to follow SOPs and regulatory guidelines with precision

Physical Requirements

• Ability to work seated or standing for 8 – 10 hours
• Ability to lift, push, pull or otherwise transport objects or weighing up to 25lbs

Qualifications/Requirements

• High school diploma or equivalent required
• At least 1 year of hands‑on experience with aseptic technique required
• Experience working in an FDA-regulated environment preferred
• An associate's or bachelor's degree in a related field may be substituted for the required one (1) year of experience
• Clearance of favorable background investigation required