Manufacturing Technician II, Lyophilization
About The Position
The Manufacturing Technician II - Lyophilization is responsible for executing all production processes while strictly adhering to cGMP, environmental health and safety guidelines, and any other applicable regulations. Under the general direction of the lead technician and overall supervision of the supervisor, this position is responsible for the hands-on execution of all activities in the production area. Additionally, this role plays a key part in manufacturing lyophilized products, organizing the lyophilization group within the Life Sciences Department, and supporting other departments and groups as needed. The Senior Laboratory Technician is expected to fully participate in departmental projects and quality working teams as applicable. All specific requirements outlined in this job description apply 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. Flexible start time is 6:00 am with a consistent schedule.
Requirements
- 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.
- 1 or more years' experience in Contract Manufacturing
- 3 or more years' experience in Formulations or Lab Bench
- 3 or more years' experience in pH/Balance/Pipette
- 5 or more years' experience in a GMP environment
- Must be punctual and maintain attendance.
- Excellent problem-solving skills and the ability to make critical decisions accordingly.
- Proven attention to detail
- 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.
- Knowledge of chemical and biological safety procedures.
- Knowledge of Formulation/Lyophilization operations and capabilities.
- Basic knowledge of microbiology and clean room workflows including aseptic technique
Responsibilities
- Ability to work within an ISO 13485 and cGMP production environment and ensure compliance with our quality system.
- This role works in a multifaceted laboratory environment executing projects of low-high complexity and criticality with multi-functional teams.
- Execute documentation based on cGMP and cGDP procedures, as well as perform documentation review post manufacturing execution.
- Support pilot manufacturing of new project introductions and sustaining projects within cGMP workflows utilizing SOPs.
- Responsible for formulation of liquid components, filling of various liquids, and creating lyophilized product in an ISO cleanroom environment.
- Handling of liquid nitrogen according to OSHA safety guidelines and lifting of heavy liquid nitrogen Dewars using proper body mechanics.
- Visual inspection of lyophilized product and liquid product.
- Perform basic-intermediate arithmetic calculations as it pertains to total volume and liquid concentrations.
- Perform daily unit conversions as it pertains to gravimetric and volumetric measurements utilizing the metric system.
- Operate laboratory equipment such as pipettes, balances, centrifuges, pH meters and heat sealers.
- Responsible for Biodecontamination (cleaning, sanitization, etc.) and appearance of all formulation and lyophilization production areas.
- Author Non-Conformance Reports (NCR) and risk analysis memos.
- May perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
