Production Technician 2 (Manufacturing/Medical Device)

Purpose

The Production Technician under direct supervision, completes the manufacturing of collagen/final product in an FDA regulated aseptic and non-aseptic clean room environment (Class 100 to 10,000) and other production processes. This role requires strict adherence to FDA regulations, industry standards in accordance with cGMP's (current Good Manufacturing Practices).

Duties and Responsibilities

• Follow written SOP's and batch records for bulk production, aseptic filling, assembly and final product labeling and packaging.
• Print and inspect controlled labels for final product.
• Perform inspection of finished products.
• Record process operations and data calculation entries into batch records and associated forms.
• Qualify for aseptic gowning and operations (syringe filling) on a semi-annual qualification basis. Manually fill syringes in an aseptic environment for extended durations while being monitored for viable and non-viable microbial growth.
• Perform line clearance prior to the commencement of each process by ensuring all related materials/components are released for use, and non-related materials/ components are not present; therefore removed.
• Ability and knowledge to operate, calibrate, and standardize equipment released for cGMP use.
• Process raw bovine in preparation for collagen extraction.
• Assemble pressurized tanks and process.
• Formulate acidic and caustic dilutions from concentrated stock.
• Process and sieve PMMA.
• Clean and sterilize (autoclave) process equipment, vessels, and cleaning.
• Perform room cleaning in aseptic and non-aseptic areas (ceilings, walls, floor, and biosafety cabinets).
• Neutralize waste using acidic or caustic solutions before.
• Maintain production areas to cGMP compliance and inspection.
• 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.
• Participate in and support implementation of changes in processes and policies to maintain high professional
• Fill voids within the production.
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings.
• Ensure completion of assigned tasks and responsibilities within defined times.
• Flexibility to work overtime and or weekends to support operational needs when necessary.
• Perform other duties as assigned.

Skills and Abilities

• Ability to work effectively in a team or independently.
• Excellent attention to detail and organization.
• Ability to cross-train.
• Ability to work seated or stand for 6-10 hours.
• Ability to lift, push, or pull objects weighing up to 25 lbs. as needed.
• 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
  
• Strong technical writing.
• Excellent documentation accuracy.
• Ability to follow SOPs and regulatory guidelines with precision.
• Proficiency in Microsoft Office.

Qualifications/Requirements

• High school diploma or general education degree required.
• At least 3 years of hands-on experience with aseptic technique or in an FDA-regulated enviroment preferred.
• A higher level of education may be considered, or equivalent combination of education and experience is preferred. 
• Experience in Biotechnology/Medical Device preferred.
• Associate’s degree (AA) in scientific discipline or equivalent from two-year college or technical school is preferred.
• Clearance of favorable background investigation is required.