Senior Quality Engineer, Environmental Controls & Monitoring
- Flexible / Remote
JUUL Labs’ mission is to impact the lives of the world’s one billion adult smokers by eliminating combustible cigarettes. We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.
We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career at one of the fastest growing companies is compelling, read on for more details.
ROLE AND RESPONSIBILITIES:
- Establishes monthly, quarterly and annual trends by compiling microbiological and environmental monitoring data; Performs data analysis and presents insights to management; recommends revisions to monitoring program and/or manufacturing process controls. Ensures effective corrective actions are implemented, where necessary.
- Lead in Cleanroom Validations. Authors protocols and reports for Cleanroom Validations.
- Lead in Environmental Controls: Develops, validates and implements controlled environment methods.
- Review and approve results from Environmental Monitoring including viable and non-viable particulate counts, product bioburden, water and surface microbial levels, etc. to ensure an appropriately controlled environment meeting regulatory expectations and industry standards.
- Lead all investigations pertaining to cleanroom excursions.
- Define and requirements for testing and compile and analyze resulting data for regulatory submissions, validations, etc.
- Participates in the preparation of investigations, summaries, and non-conformance reports and initiates protocols and final reports.
- Lead microbiological testing for stability studies. Review/Approve all data upon completion of stability studies.
- Drive continuous improvement of environmental controls by performing risk assessments in classified areas.
- Lead review of microbiology policy, procedures, work instructions, protocols, etc. on an annual basis to assure compliance with regulatory requirements.
- Lead the authoring and/or review for microbiology sections of global regulatory submission documents in support of Regulatory Affairs.
- Responsible for providing microbiology expertise globally for due diligence reviews of changes made to existing products and introduction of new products.
- Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.
- Provides microbial technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control.
- Serves as technical liaison with functional groups, contract laboratories and manufacturing sites.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 5+ years in microbiology supporting a pharmaceutical, medical device or equivalent other regulated manufacturing environment.
- Extensive experience in working with third party laboratories and contract manufacturers.
- Expert level knowledge in Cleanroom Validations, Air Filtration Systems, and ISO Class 8 Cleanrooms.
- Expert level knowledge in developing and maintaining Environmental monitoring programs and developing product specifications for limits on microbiological contamination.
- Expert understanding of ISO 14644-1, ANSI/AAMI 72.
- Expert level knowledge of Aseptic Technique and Microbiological Methods.
- Knowledge of GMP, ISO standards, and global regulatory requirements for products manufactured in cleanroom environments.
- Demonstrated ability to effectively interact with and collaborate at all levels in the organization and with external stakeholders, including effective interfaces at the senior management level.
- Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, etc.
- Strong ability to balance multiple priorities with excellent time management skills.
- Ability to read and interpret documents related to medical device sterilization and cleanrooms Including: International standards, regulations, technical procedures, journals, regulatory publications. Familiarity with FDA regulations.
- Detail oriented with the ability to work under pressure.
- Ability to travel up to 50%, as needed (domestic or international).
EDUCATION: B.S. or M.S. in Biology, Microbiology or equivalent academic qualifications and work experience required.
JUUL LABS PERKS & BENEFITS:
- A place to grow your career. We’ll help you set big goals - and exceed them
- People. Work with talented, committed and supportive teammates
- Equity and performance bonuses. Every employee is a stakeholder in our success
- Boundless snacks and drinks
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits
JUUL Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. JUUL Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for JUUL Labs in the US.
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