BioLife Solutions is repeatedly named one of Washington’s 100 Best Companies to Work For, a list curated by Seattle Business Magazine. We welcome you to apply to join our dynamic, high-energy team. Here you will find a performance-based, family-oriented environment where authentic communication and treating colleagues with respect are required. Our employees receive a competitive benefits package, which includes generous company stock awards and a 401k matching program.
BioLife Solutions is a leading developer, manufacturer and supplier of class-defining cell and gene therapy bioproduction tools and services. Our solutions facilitate basic and applied research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. Our solutions offer commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of biologic materials. Our tools portfolio includes our proprietary, serum-free and protein-free, fully defined CryoStor® freeze media and HypoThermosol® shipping and storage media, ThawSTAR® family of automated, water-free thawing products, evo® cold chain management system, and Custom Biogenic Systems high-capacity storage freezers. Services include SciSafe biologic and pharmaceutical materials storage. For more information, please visit: www.biolifesolutions.com
General Summary and Purpose:
The Aseptic Technician I is a core team member of the manufacturing team. The Aseptic Technician I is responsible for daily production including environmental monitoring, formulating, and sterile filling of aseptic GMP manufactured products according to batch records and SOPs. This position allows for exposure to many department’s ways of working and opportunities for cross functional projects. Allows for insight into the world of biotechnology.
Duties and Responsibilities:
- 90-95% of job duties will be directly related routine processes of bulk formulation, filling, and packaging of Quality System regulated compliant media products. This includes but is not limited to:
- Working inside cleanroom suites on your feet for several hours at a time
- Disinfecting and transferring materials and equipment into the cleanroom for production
- Performing environmental monitoring
- Weighing, measuring, and checking raw materials to ensure batches manufactured contain proper ingredients and quantities.
- Aseptically filling solutions into finished product containers under sterile conditions
- Performing washing and disinfection of lab ware used in GMP manufacture.
- Performing cleaning of equipment and classified cleanrooms facility (ceiling, walls, critical surfaces, and floors)
- Performing repetitive tasks while gowned (hood, mask, coveralls, boots, gloves, etc.)
- Operating equipment such as balances, volumetric glassware, peristaltic pumps, filters, pH meter, and pipettes
- Performing all tasks while following all SOPs, batch records, and safety policies
- Accurately completing batch record documentation, all appropriate logbook entries, and GMP documentation
- 5-10% of job duties will include indirect manufacturing support projects. This includes but is not limited to:
- Performing preventive maintenance on manufacturing equipment following SOPs
- Performing tasks that contribute to process improvements.
- Other projects and duties as required.
- Required to be on-call for equipment monitoring on a rotation.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
This position reports to Head of Manufacturing
- Relevant life sciences manufacturing experience and familiarity with aseptic processes in a cGMP/FDA regulated environment, and/or two years of college-level science coursework with an interest in pharmaceutical manufacturing
- Self-motivated and willing to accept temporary responsibilities outside of normal job duties
- Comfortable working in a fast-changing small company environment and able to adjust work load based on changing priorities
- Must not have unusual sensitivity to typical laboratory chemicals (i.e. sanitization agents)
- Must be able to perform fast paced operations and repeatedly perform multi-step simultaneous operations with a high degree of accuracy
- Effectively communicate while wearing cleanroom gowning (mask, hood, coveralls, gloves, etc.)
- Must be able to work effectively in a group and independently
- Must be able to meet aseptic gowning qualification requirements
- Must be able to work regularly with cleaners
- May be required to work either day or evening shift as needed
- May occasionally be required to work weekends and overtime as needed
- Must be able to lift up to 50 lbs. and push/pull up to 1200 lbs. with assistance
- Education Minimum: Two years of college-level biological coursework, i.e. in Chemistry, Biology, Physics, etc. or one-year experience working in a GMP Manufacturing setting is required.
- Experience Requirement Minimum: Prior aseptic gowning and processing techniques is desirable. Knowledge of Lean/Six Sigma/5S a plus.
- Software Used: Familiarity with Microsoft Office programs (Word, Excel, Outlook) is desirable.
BioLife Solutions provides a substance-free workplace, and all offers of employment will be contingent on opiate drug test and background check.
BioLife Solutions is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.