Aseptic Technician I jobs in United States
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BioLife Solutions, Inc. · 6 hours ago

Aseptic Technician I

BioLife Solutions is a leading developer and supplier of cell and gene therapy bioproduction tools and services. The Aseptic Technician I will be responsible for daily production tasks including environmental monitoring, formulation, and filling of aseptic GMP manufactured products, while also providing support for manufacturing equipment and quality investigations.

Biotechnology
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H1B Sponsor Likelynote

Responsibilities

90-95% 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
5-10% 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 batch record and SOP revisions
Proposes champions and implements process improvements
Real time review of production records (GDP) ensuring operators are documenting procedures in real time
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

Qualification

Aseptic processingCGMP/FDA regulationsEnvironmental monitoringBatch record documentationLean/Six Sigma/5SMicrosoft OfficeTeam collaborationCommunication skills

Required

Bachelor's degree; or Associate degree / Biotech cert and 1 year of relevant experience; or High school diploma / GED and 2 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 aseptic processing in a cGMP/FDA regulated environment is desirable
Prior cleanroom gowning experience is desirable
Familiarity with Lean/Six Sigma/5S is desirable
Degree in sciences with an interest in pharmaceutical manufacturing is desirable
Familiarity with Microsoft Office programs (Word, Excel, Outlook) is desirable

Benefits

401K with generous match
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.

H1B Sponsorship

BioLife Solutions, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2020 (1)

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