Bioprocess Technician II/III - Argonaut Manufacturing Services

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Pay Range

The pay range for this position is between $20.00 - $26.00 per hour. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. This is a temp to hire position.

Position Overview

The Bioprocess Technician is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. The Manufacturing Technician is expected to fully participate in both departmental projects and any quality working teams which may be applicable. existing procedures. All of the specific requirements presented in this job description are applicable to the functional area in which it resides.

This role is 100% on-site, Monday - Friday, 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. This role is 12:00 pm - 8:30 pm with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

• Ability to work within an ISO 13485 and cGMP production environment and ensure compliance with our quality system.

• Execute documentation based on cGMP and GDP procedures, as well as perform documentation review post manufacturing execution.

• Participate in Quality Working Teams and Continuous Improvement Teams.

• Responsible for formulation of liquid assays, operation of large equipment, creating lyophilized product in an ISO cleanroom environment, daily washing of regularly used tools.

• Visual inspection of lyophilized product and heat seals of packaging.

• Clean and sanitize manufacturing and associated support areas.

• Responsible for monitoring machinery and reporting alarms to lead technician or Supervisor.

• Conduct daily documentation review.

• Participate in Quality Working Teams and Continuous Improvement Teams.

• Operate large machinery and monitor automated.

• Manually clean equipment and perform preventative maintenance.

• Employee may be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.

• Handling of liquid nitrogen according to OSHA safety guidelines.

• Lifting of heavy liquid nitrogen Dewars using proper body mechanics.

• Loading/Unload materials to automated machines and lyophilizers.

• Responsible for Biodecontamination and appearance of all formulation and lyophilization production areas.

• Prepare liquid solutions for freezing into solid product.

• Perform daily arithmetic calculations as it pertains to total volume and liquid concentrations.

• Perform daily unit conversions as it pertains to gravimetric and volumetric measurements.

• Operate production equipment such as pipettes, balances, pH meter and heat sealers.

• Monitor department equipment for proper operation that is within calibration.

• May perform safety and cGMP inspections or observations.

• Ensure compliance with SOP/cGMP and cGDP requirements.

• Assist in training/ leading of new team members in production activities.

• Assist in updating and new revision of standard operating procedures (SOP).

• Author Non-Conformance Reports (NCR) and risk analysis memos.

• Receive and distribute supplies into the production area as necessary.

• Perform NetSuite transaction, issue material , completion and closing of work orders.

• May assist with review of quality assurance logbooks.

• May perform other duties as assigned.

Requirements and Qualifications

Level II: Requires a bachelor's degree in a related field and at least 1 year of work experience at Argonaut or in similar/related industry; or high school diploma with 3 years' related work experience.

Level III: Requires a bachelor's degree in a related field and at least 5+ years' of work experience at Argonaut; or high school diploma with at least 5+ years' related work experience.

• Must be punctual and maintain attendance.

• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

• Must be able to read, write, and converse in English to train and understand cGMP manufacturing and SOP's.

• Understands Manufacturing Production Processes as it pertains to product integrity processes; visual inspection of components, finished goods; manual and semi-automated packaging; product labeling.

• Knowledge of basic chemical and biological safety procedures.

• Basic Knowledge of Formulation/Lyophilization operations and capabilities.

• 3 or more years' experience in Formulations or Lab Bench

• 5 or more years' experience in a GMP environment

• 1 or more years' experience in Contract Manufacturing

• 3 or more years' experience in pH/Balance/Pipette

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies will all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.