Production Technician III
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Production Tech to work for a leading San Diego biotechnology company.
Production Technician III
The manufacturing of collagen/PMMA product in a FDA regulated aseptic and non-aseptic clean room environment (Class 100 to 10,000) in accordance with cGMP's (current Good Manufacturing Practices) and other applicable regulatory requirements, such as ISO and OSHA.
- Follow written SOP’s and batch records for lean manufacturing and aseptic filling of final product, which includes inspection, labeling, and final product packaging. Record process operations and data calculation entries into batch records.
- Qualify for aseptic gowning and operations (syringe filling) on a semiannual 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 the all related materials/components are released for use, and non-related materials/components are not present; therefore removed.
- Process raw bovine in preparation for collagen extraction and purification.
- Assemble pressure and vacuum tanks and process equipment.
- Formulate acidic and caustic dilutions from concentrated stock solutions.
- Process and sieve PMMA microspheres.
- Print and inspect controlled labels for final product packaging.
- Perform 100 percent inspection of product syringes (skin test and PMMA/collagen).
- Clean and sterilize (autoclave) process equipment, vessels, and cleaning equipment.
- Clean non-aseptic and aseptic areas (ceilings, walls, floor, and biosafety cabinets).
- Neutralize waste using acidic or caustic solutions before discarding.
- Participate and support implementation of changes in processes and policies to maintain high professional standards.
- Fill voids within the production operation, as required.
- Maintain compliance with all Quality Systems requirements. Fully adhere to all applicable FDA regulations, international guidelines and company policies at all times.
- Ability to work effectively under fully gowned clean room conditions for extended periods of time.
- High School Diploma or equivalent.
- Minimum 4 years Biotech/Pharmaceutical manufacturing and cGMP experience
- Experience or knowledge of Kaizen manufacturing principles (JIT, 5S)
- Good interpersonal skills
- Experience with assembly, equipment sanitization, and clean room practices is required.
- Prior experience with aseptic processing, collagen manufacturing is beneficial.
- Experience in an aseptic clean room class 100 environment is a plus.
- Occasionally the employee will be required to lift or move at least 50 pounds.
- Ability to work overtime and weekends are required on an as needed basis.