Position Title: Bioprocess Manufacturing Technician
Work Location: Oceanside, CA 92056
Assignment Duration: 12 months
Work Schedule:
• 10 hr Day Shift, 6:00 am – 4:30 pm — Sunday-Wednesday or Wednesday-Saturday
• 10 hr Mid Shift, 10:00am-08:30PM — Sunday-Wednesday or Wednesday-Saturday
• 10 hr Swing Shift, 12:30 pm -11:00 pm — Sunday-Wednesday or Wednesday-Saturday
• 10 hr Swing Shift, 1:30 pm -00:00 am — Sunday-Wednesday or Wednesday-Saturday
• Onboarding will consist of a 3-4 week schedule of Monday thru Friday 8am - 5pm followed by on the job training on the respective shift schedule.
Work Arrangement: Onsite

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.
• This is a contract role with the possibility of conversion to a permanent employee position. We have both Stainless Steel and Single-Use Manufacturing facilities that are supported by Production Services.

Background & Context:
There are 3 main production areas within manufacturing:
• Production Services - Responsible for weighing and aliquoting of raw materials and small scale solution prep. Also responsible for washing, autoclaving, and preparation of small equipment parts and assemblies. Responsible for environmental monitoring of the facility.
• Upstream Manufacturing - Responsible for cell growth from inoculation in spinner flasks through large scale bioreactors and the harvesting of cell culture via centrifugation and depth filtration.
• Downstream Manufacturing - Responsible for the purification of cellular harvest utilizing chromatography and reformulation techniques, as well as preparation of product for shipping to final fill/finish sites.

Key Responsibilities:
• Safety is paramount to both our employees and our patients, and is therefore at the core of all job responsibilities. This includes complying with all safety requirements, cGMP, Standard Operating Procedures (SOP) and manufacturing documentation.
• Utilizing automated systems to operate, clean and sterilize production equipment
• Operating small-scale cell culture areas and systems by using aseptic techniques, maintaining cell banks; and performing general seed lab operations
• Operating fermenters, centrifuges, other harvest systems and protein purification units
• Operating and cleaning fixed tank and filtration systems
• Operating large scale column chromatography systems
• Preparing solutions required for the production process (media and buffer make-up)
• Cleaning, assembling, and sterilizing equipment for production by operating glass washers and autoclaves
• Executing environmental monitoring throughout the facility

Qualification & Experience:
• Proficiency in the English language- reading, writing, and communication.
• Must be computer literate due to the extensive automation used in our facility, experience with Microsoft and Google platforms.
• Must be able to work all shifts, required overtime as needed, and stand for extended periods of time.
• Our facility is expansive - you may climb multiple flights of stairs daily
• Lifting up to 25 lbs is required.
• The cleanroom environment requires gowning in the form of cleanroom scrubs, bunny suits, gloves, hair covers, safety glasses, and steel toe boots be worn.
• No makeup or jewelry can be worn when working in the clean room environment. Personal electronic devices (e.g. cell phones) are not permitted in cleanrooms without formal approval due to health authority regulation.
• You may work with hazardous materials and chemicals
• 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.

Educational Requirements:
• High school diploma or equivalent
• Preferred - Degree in Life Sciences/Engineering, Associate’s or Biotech certificate from approved program 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $22.00/hr - $24.44/hr.