Aseptic Technician III jobs in United States
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BioLife Solutions, Inc. · 3 hours ago

Aseptic Technician III

BioLife Solutions is a leading developer, manufacturer and supplier of bioproduction tools and services. The Aseptic Technician III is responsible for daily production activities including environmental monitoring and aseptic filling of GMP manufactured products, while also supporting indirect manufacturing projects.

Biotechnology
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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
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
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
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

Qualification

GMP knowledgeAseptic techniqueEnvironmental monitoringCleanroom experienceLean/Six SigmaMicrosoft OfficeProblem-solving skillsTeamworkCommunication skills

Required

Bachelor's degree and 2 year of manufacturing 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

Preferred

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

Benefits

Generous company stock awards
401k matching program
Medical
Dental
Vision
Life and disability insurance
Vacation and Sick time
Cash bonus or stock equity grants based on company performance

Company

BioLife Solutions, Inc.

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Preserving the Promise™ The human body can heal itself.

Funding

Current Stage
Growth Stage

Leadership Team

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Sean Werner
Chief Technology Officer- Cell Processing
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Troy Wichterman
Chief Financial Officer
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Company data provided by crunchbase