Aseptic Manufacturing Technician I,II, III Shift (12pm -8:30 pm PST)

Full Time
Bothell, WA 98021
$36,565 - $88,786 a year
Posted
Job description

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 is a core team member of the manufacturing team. The Aseptic Technician is
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. This
position provides an opportunity to solve challenges in a fast-growing industry.
BioLife in a fast-growing company that is the leading cell preservation specialist within the fields of
biotechnology and pharmaceuticals. 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.

  • Aseptic Technician I
    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 SOP
  • Performing tasks that contribute to process improvements.
  • Other projects and duties as required.

Salary Range - $43,054 – $62,418


Aseptic Technician II

Duties and Responsibilities:

  • 40-60% of job duties will be directly related routine processes of bulk formulation, filling, and packaging
    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 follow all SOPs, batch records, and safety policies.
  • Accurately complete batch record documentation, all appropriate logbook entries, and GMP
    documentation
  • 40-60% 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.
  • Able to train others and be a source of knowledge and information.
  • Real time review of production records (GDP) ensuring operators are documenting
    procedures 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.
  • Duties, responsibilities, and activities may change at any time with or without notice.
    Salary Range : - $48,719 – $70,658

Aseptic Technician III
Duties and Responsibilities:
50-70% 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:

  • 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 follow all SOPs, batch records, and safety policies.
  • Accurately complete batch record documentation, all appropriate logbook entries, and GMP
    documentation
  • 30-50% of job duties will include indirect manufacturing support projects. This includes but is not
    limited to:
  • Perform preventive maintenance on equipment.
  • Trouble shoot malfunctioning equipment.
  • Independently lead root cause investigations for quality issue
  • Proposes, champions, and implements process improvements.
  • Oversee activities on production floor ensuring compliance with Aseptic technique and
    documented processes.
  • Design, develop, and lead validation activities
  • Perform batch record and SOP revisions.
  • Real time review of production records (GDP) ensuring operators are documenting
    procedures real time.
  • Identify, develop, and implement projects that contribute to process improvements and
    regulatory compliance.
  • Lead cross departmental projects
  • Training new manufacturing team members
  • 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.

Salary Range : $53,869 - $80,752


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:

  • Familiarity with aseptic processes in a cGMP/FDA regulated environment is desirable but not
    required.
  • College-level science coursework with an interest in pharmaceutical manufacturing is desirable but
    not required.
  • 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.
  • 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


Job Specifications:


Level I

  • Education Minimum: H.S. diploma or equivalent required
  • 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 but not required.
  • Software Used: Familiarity with Microsoft Office programs (Word, Excel, Outlook) is desirable.

Level II

  • In addition to the requirements listed above, Aseptic Technician II requires 1 year of experience in
    GMP setting, with prior aseptic gowning and processing techniques.
  • Knowledge of Lean/Six Sigma/ 5S
  • Software: Familiarity with Microsoft Office Programs

Level III

  • In addition to the requirements listed above, Aseptic Technician III requires 2+ years of experience in
    GMP setting, with prior aseptic gowning and processing techniques.
  • Highly organized and strong attention to detail
  • Able to problem solve and know when it is appropriate to escalate problems to management.
  • Self-starter with the ability to work in a high pace team environment, meeting deadlines, and adjusting
    workload based on changing priorities.
  • Must be able to perform fast paced, repetitive, multi-step operations with a high degree of accuracy.

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.


The US base salary range for this position at full-time is $36,565 - $88,786 (yr). Our salary ranges are determined by position, level, location, and market competitive benchmarks. Individual pay within a level is determined by work location, job related skills, experience, education, and training.


The BioLife Solutions total rewards program includes, but is not limited to medical, dental, vision, 401K with generous match, life and disability insurance as well as time off programs of Vacation and Sick time. Additionally, we believe in our team members sharing the success of our business and therefore we provide stock equity grants as a part of our total rewards package.

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