Aseptic Technician III - Bothell - BioLife Solutions

Description

Aseptic Technician III

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.

General Summary and Purpose:

The Aseptic Technician III is a core team member of the manufacturing team. The Aseptic Technician III 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.

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.
• 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 employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Requirements:

• 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.

Job Specifications:

• 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.
• May be required to work either day or evening shift as needed.
• May occasionally be required to work weekends and overtime as needed.
• Familiarity with Lean/Six Sigma/5S is desirable.

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. BioLife Solutions participates in E-Verify. BioLife Solutions provides a substance-free workplace, and all offers of employment will be contingent on opiate drug test and background check.

The US base salary range for this position at full-time is $58,259 $87,333 per year. Typically, new hires are brought in at or near the midpoint of the range to allow for future growth and advancement within the role. This range represents the full compensation range for this position, with consideration given to experience, skills, qualifications. Our salary ranges are determined by position, level, location, and market competitive benchmarks. Individual pay within a level is determined by work location (including geographic pay zone region), 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 may provide cash bonus or stock equity grants based on company performance as a part of our total rewards package.