Biotechnical Manufacturing Technician

Amnio Technology; Phoenix (AZ); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading company specializing in amnion-derived technologies is looking for an Entry Level Biotechnical Manufacturing Technician in Phoenix, AZ. The role involves adhering to strict manufacturing protocols and quality standards while supporting the production of biologic products. Candidates should have experience in regulated environments and possess strong communication skills to thrive in this collaborative setting.

Qualifications

• Knowledge of process science involved in production.
• Strong understanding of QMS requirements.
• At least one year experience in a regulated environment.

Responsibilities

• Manufacture biologic products according to SOP.
• Document tasks on Batch Records per SOP.
• Ensure product and process quality.

Skills

Communication

Problem Solving

Teamwork

Understanding of QMS

Computer Proficiency

Education

Relevant experience in regulated environments

Job description

Join to apply for the Biotechnical Manufacturing Technician role at Amnio Technology

General Responsibilities

The Manufacturing Technician at Amnio Technology, LLC (“AT”) assists in the manufacturing of Amnio Technology’s aseptically produced biologic product. The Technician operates in accordance with current good manufacturing (cGMP) standards as part of a comprehensive Quality Management System compliant with cGTP regulations, and industry standards (FDA, AATB), to support regulatory filings, new product development, and ongoing commercial production of AT’s Biologic and Tissue products.

Initial responsibilities include following established SOPs, industry standards, and safety policies to manufacture biologic products. Documenting tasks performed in accordance with cGDP. Performing process and equipment cleaning, calibration, and validation as assigned.

Education & Work Experience Qualifications

• Strong understanding of QMS requirements in regulated environments (FDA, AATB).
• Knowledge of process science and technology involved in the production of allografts or drugs for surgical implantation.
• Knowledge of raw materials, production processes, and quality control for allografts or drugs.
• Understanding of SOP content requirements.
• Excellent written and oral communication skills.
• Ability to assess tasks, identify challenges, and communicate effectively.
• Ability to work independently and as part of a team.
• At least one year’s experience in a regulated environment, preferably pharmaceutical, medical device, or biologics. Relevant manufacturing/engineering experience preferred.
• Aseptic processing experience preferred.
• Computer proficiency.

Essential Duties & Responsibilities

• Manufacture biologic products according to SOP.
• Document tasks on Batch Records and other documents per SOP and cGDP.
• Ensure product and process quality, report deviations.
• Report errors or obstacles promptly.
• Store and prepare manufacturing materials per SOP.
• Participate in equipment and facility maintenance and cleaning.
• Assist in validation and calibration activities.
• Participate in incident and deviation investigations.
• Communicate professionally with all levels of management.
• Assist with special projects as needed.

Company Description

Amnio Technology, LLC is a global leader in amnion-derived technologies, focusing on optimizing the regenerative potential of amniotic tissues for wound healing and other applications.

Additional Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Management and Manufacturing