Aseptic Technician III

at  BioLife Solutions

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

ASEPTIC TECHNICIAN III

Duties and Responsibilities:

• 60-70% of job duties will be directly related to routine processes of bulk formulation, filling, and packaging of Quality System regulated compliant media products. This includes but is not limited to:
• Disinfecting and transferring materials and equipment into the cleanroom for production.
• Working inside cleanroom suites on your feet for several hours at a time.
• Perform environmental monitoring.
• Weighing, measuring, and checking raw materials to ensure batches manufactured contain proper ingredients and quantities.
• Aseptically fill solutions into finished product containers under sterile conditions.
• Perform washing of labware used in GMP manufacture.
• Perform cleaning of equipment and classified cleanrooms facility (ceiling, walls, critical surfaces, and floors).
• Performing repetitive tasks while gowned (hood, mask, coveralls, boots, gloves, etc.)
• Operate equipment such as balances, volumetric glassware, peristaltic pumps, filters, pH meter, and pipettes.
• Perform all tasks while following all SOPs, batch records, and safety policies.
• Accurately complete batch record documentation, all appropriate logbook entries, and GMP documentation
• 30-40% of job duties will include indirect manufacturing support projects. This includes but is not limited to:
• Perform preventive maintenance on manufacturing equipment.
• Perform root cause investigations for Quality issues.
• Perform validation activities as needed.
• Perform batch record and SOP revisions.
• Proposes champions and implements process improvements.
• Supports training program sharing knowledge of process.
• Training new manufacturing team members and being a source of knowledge and information.
• Real time review of production records (GDP) ensuring operators are documenting procedures in real time.
• Lead cross departmental projects.
• Other projects and duties as required.
• May be required to work either day or evening shift as needed.
• May occasionally be required to work weekends and overtime as needed.
• Required to be on-call for equipment monitoring on a rotation.
• Duties, responsibilities, and activities may change at any time with or without notice.

Other Duties:
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 team member for this job. Duties, responsibilities, and
activities may change at any time with or without notice.
Reporting Relationships:
Position reports directly to the Manufacturing Manager and Manufacturing Team Leads

JOB REQUIREMENTS:

• Bachelor’s degree and 2 years of relevant experience; or Associate degree / Biotech cert and 3 years of relevant experience; or High school diploma / GED and 4 years of relevant experience
• 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 workload 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.
• Must be able to lift up to 50 lbs. and push/pull up to 1200 lbs. with assistance.

• 60-70% of job duties will be directly related to routine processes of bulk formulation, filling, and packaging of Quality System regulated compliant media products. This includes but is not limited to:
• Disinfecting and transferring materials and equipment into the cleanroom for production.
• Working inside cleanroom suites on your feet for several hours at a time.
• Perform environmental monitoring.
• Weighing, measuring, and checking raw materials to ensure batches manufactured contain proper ingredients and quantities.
• Aseptically fill solutions into finished product containers under sterile conditions.
• Perform washing of labware used in GMP manufacture.
• Perform cleaning of equipment and classified cleanrooms facility (ceiling, walls, critical surfaces, and floors).
• Performing repetitive tasks while gowned (hood, mask, coveralls, boots, gloves, etc.)
• Operate equipment such as balances, volumetric glassware, peristaltic pumps, filters, pH meter, and pipettes.
• Perform all tasks while following all SOPs, batch records, and safety policies.
• Accurately complete batch record documentation, all appropriate logbook entries, and GMP documentation
• 30-40% of job duties will include indirect manufacturing support projects. This includes but is not limited to:
• Perform preventive maintenance on manufacturing equipment.
• Perform root cause investigations for Quality issues.
• Perform validation activities as needed.
• Perform batch record and SOP revisions.
• Proposes champions and implements process improvements.
• Supports training program sharing knowledge of process.
• Training new manufacturing team members and being a source of knowledge and information.
• Real time review of production records (GDP) ensuring operators are documenting procedures in real time.
• Lead cross departmental projects.
• Other projects and duties as required.
• May be required to work either day or evening shift as needed.
• May occasionally be required to work weekends and overtime as needed.
• Required to be on-call for equipment monitoring on a rotation.
• Duties, responsibilities, and activities may change at any time with or without notice