Bioprocess Manufacturing Technician

Position Title: Bioprocess Manufacturing Technician

Work Location: Oceanside, CA, 92056

Assignment Duration: 2 years

Work Arrangement: Onsite

Work Schedule: 10 hr Day Shift, 6:00 am - 4:30 pm (Sunday - Wednesday or Wednesday - Saturday) OR 10 hr Swing Shift, 12:30 pm -11:00 pm (Sunday - Wednesday or Wednesday - Saturday).

Onboarding may consist of multi-week Monday - Friday 8am - 5pm followed by on-the-job training.

Position Summary:

• As a Bioprocess Manufacturing Technician, you will be responsible for producing medicine in a highly automated and controlled environment. Each product has a specific recipe; you will follow this recipe, along with the standard operating procedures, to operate the production equipment across various areas, including raw material dispensing/aliquoting, cell culture and purification.
• You will maintain records and follow all the steps necessary to comply with regulatory requirements within a current Good Manufacturing Practices (cGMP) environment.

Key Responsibilities:

• Producing medicine in a highly automated and controlled environment by following specific recipes and standard operating procedures.
• Operating production equipment across various areas, including raw material dispensing/aliquoting, cell culture and purification.
• Maintaining records and following all steps necessary to comply with regulatory requirements within a cGMP environment.
• Working within a team to produce and deliver quality products.
• Working in a safe manner and following Standard Operating Procedures at all times.
• In Upstream: preparing the medium needed for cell growth and maintaining Cell Cultures which includes the set-up and breakdown of stainless steel bioreactors.
• In Downstream: working on a series of operations to isolate, purify, and concentrate the product. This includes preparation of Buffers, cleaning and steaming in place Chromatography skids, and supporting formulation.
• In Production Services Area: performing the weighing and aliquoting of raw materials into intermediate bulk containers for use in our stainless steel facility.
• Supporting single-use operations by kitting materials and preparing small-scale solutions.
• Washing, autoclaving, and preparing small equipment parts and assemblies.
• Conducting environmental monitoring throughout the facility.

Qualification & Experience:

• Proficiency in the English language- reading, writing, and communication.
• Must be able to work all shifts, required overtime as needed, and stand for extended periods of time.
• Must be able to interface with computer systems to successfully operate manufacturing equipment. Experience with distributed control systems or other manufacturing automation is preferred.
• Must be able to successfully pass all job-related tests and certifications required for working in a cGMP quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job.
• Must re-qualify every year on all job-related training and certifications as job or qualifications require.
• May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
• Lifting up to 25lb may be required.
• The cleanroom environment requires that company provided gowning is worn. This may include plant uniform, coveralls, gloves and safety shoes. Additionally, regulations prohibit makeup, jewelry, and other personal items from entering the clean room environment.
• Scientific and technical degrees preferred, e.g. Life Science or Engineering.
• Experience in a GMP working environment is highly desired with experience in the operation of complex mechanical equipment used in the washing, autoclaving, processing, and assembly of parts used in Upstream or Downstream processes.
• Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.
• Understands the theory, concepts, and regulations behind biopharma technology and processes.
• Experience in clean room environment and familiarity with cGMP and ISO/FDA standards is strongly preferred.
• Hardworking and fast learning individual that thrives in a high paced environment.
• Ability to think critically and work both tactically and strategically.
• Strong quality mindset with attention to detail and a desire to deliver service excellence.
• Ability to work effectively with others, exhibiting a professional manner and establish constructive working relationships.
• Experience with biologics manufacturing is not necessary but preferred.
• Relocation benefits are not available for this posting. We currently do not sponsor work visas for this position or offer relocation assistance.