Aseptic Technician II- Morning Shift

Biolife Solutions•Bothell, WA

5d•Onsite

About The Position

BioLife Solutions is a leading developer, manufacturer, and supplier of cell and gene therapy bioproduction tools and services. Our solutions facilitate research and commercialization of new therapies by maintaining the health of biologic source material and finished products during manufacturing, storage, and distribution. We offer commercial companies and clinical researchers significant improvements in shelf life and post-preservation viability and function of biologic materials. Our tools portfolio includes proprietary, serum-free and protein-free, fully defined CryoStor® freeze media and HypoThermosol® shipping and storage media, and the ThawSTAR® family of automated, water-free thawing products. The Aseptic Technician II is a core team member of the manufacturing team, responsible for daily production including environmental monitoring, formulating, and filling of aseptic GMP manufactured products according to batch records and SOPs. This position is for an experienced manufacturing professional with knowledge of GMP, aseptic technique, and problem-solving skills, offering an opportunity to solve challenges in a fast-growing industry.

Requirements

Bachelor’s degree and 1 year of manufacturing experience; or Associate degree / Biotech cert and 2 years of relevant experience; or High school diploma / GED and 3 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.

Nice To Haves

Familiarity with Microsoft Office programs (Word, Excel, Outlook) is desirable.
Familiarity with aseptic processes in a cGMP/FDA regulated environment is desirable.
Prior cleanroom gowning experience is desirable.
Familiarity with Lean/Six Sigma/5S is desirable.

Responsibilities

Disinfecting and transferring materials and equipment into the cleanroom for production.
Working inside cleanroom suites on your feet for several hours at a time.
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 of labware 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.
Performing preventive maintenance on manufacturing equipment.
Performing root cause investigations for Quality issues.
Performing validation activities as needed.
Performing batch record and SOP revisions.
Proposing, championing, and implementing process improvements.
Supporting the training program by sharing knowledge of processes.
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.