JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based vapor product. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, JUUL Labs is disrupting one of the world’s largest and oldest industries.
We’re an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.
ROLE AND RESPONSIBILITIES:
The Manager, Validation Engineering will lead the team of Validation Quality Engineers to support Manufacturing, Supplier Development, New Product Development, and Quality Systems at our contract manufacturing and suppliers. Directs projects to ensure the manufacture of high-quality product and facilitate compliance with regulatory requirements.
- Monitors daily work operations and provides direction and guidance to, experienced exempt employees to achieve unit or project goals.
- Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
- Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
- Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, regulations etc).
- Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
- Translates department goals into individual objectives.
- Identifies, develops and implements processes to improve department performance.
- Monitors departments activities and records to ensure compliance independent action through critical decision making.
- Supports validation programs related to ISO13485 and 21 CFR Part 820 guidelines and documentation.
- Assists in equipment design and URS.
- Drives projects using technical expertise and knowledge of FDA's GMP regulations (QSR 820 and 210/211), and ISO 13485.
- Coaches and Mentors project teams to develop validation strategies and the execution of the strategies.
- Writes, reviews and approves IQ, OQ and PQ protocols for manufacturing processes, systems, and equipment.
- Writes, reviews, and approves completion reports related to IQ, OQ, and PQ protocols.
- Approves protocols and reports through document control.
- Writes, reviews, and approves test method validations (TMVs) protocols and completion report.
- Knowledge of various manufacturing processes.
- Ability to travel up to 25 - 50%
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 7+ years of industry experience in Quality Engineering, Manufacturing Engineering, and/or Validation Engineering in a regulated industry such as medical device or pharmaceutical.
- 3+ years of experience in supervising or managing small team (5-10 people)
- Thorough knowledge of FDA regulations, especially 21 CFR Part 820 and ISO 13485.
- Technical writing proficiency (e.g., protocols, analytical reports, DCOs, SOPs, Test Methods, procedures)
- Working knowledge of risk management (pFMEAs), SPC, Capability Analysis, Gage R&R, Attribute Agreement Analysis, DOE, and other quality engineering tools such as statistical data analysis, and inspection techniques.
- Solid problem analysis and decision-making ability and leadership skills
- Computer literacy with Microsoft Professional Office Suite and/or Google Productivity pack and statistical software such as Minitab or JMP.
- Excellent verbal and written communication skills
- Strong organizational skills along with attention to detail
- Ability to work both independently and collaboratively with small, cross-functional teams
- Experience with high volume automation equipment is preferred
EDUCATION: BS or MS degree in Bachelor's degree in Engineering or Applied Science
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
- Catered lunch, boundless snacks and drinks
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits
- Location. Work in the heart of San Francisco, one of the world’s greatest cities
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.