Staff Microbiology Specialist

Johnson & Johnson•Santa Clara, CA

4d•$109,000 - $174,800•Onsite

About The Position

Johnson & Johnson is hiring for a Staff Microbiology Specialist – Shockwave Medica l to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Staff Microbiology Specialist works closely and partners with internal departments to efficiently deliver safe and effective medical device designs for manufacturing, which are in line with Shockwave Medical Inc. (SWMI) policies and procedures. Staff Microbiology Specialist provides Quality Assurance support to functions with a focus on Microbiology aspects, as part of sustaining and design control activities in accordance with ISO 13485, ISO 14971, ISO 11137, ISO 11737, ISO 11135, ISO 14644, ISO 8573, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other relevant standards/regulations. This includes supporting project teams across multiple SWMI sites/business units to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines.

Requirements

Bachelor of Science degree in Biology. Master’s Degree is preferred.
7+ years of hands-on progressive experience working in Quality, within the Medical Device industry.
Working knowledge of applicable medical device regulations such as ISO 13485, ISO 14971, ISO 11137, ISO 11737, ISO 11135, ISO 14644, ISO 8573, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required.
Ability to perform multiple tasks concurrently with accuracy.
Ability to understand regulatory implications of Design/Process Changes.
Ability to take a hands-on approach and lead cross-functional teams in problem solving and risk analysis activities.
Must have demonstrated hands-on experience in:
Sterilization Validation and associated process controls
Microbiology Testing and Controls
Design Verification and Validation.
Hazard/Risk Analysis.
FDA Good Manufacturing Practices (GMP).
Clear and effective communication skills
Must be able to communicate effectively with all levels of the organization in both verbal and written formats.
Proficiency in MS Word, Excel and Power Point required.
High attention to detail and accuracy is required.
Experience with statistical software such as Minitab and the application of valid statistical techniques for data analysis.
Ability to work in a fast-paced environment while managing multiple priorities.
Operate as a team and/or independently while demonstrating flexibility to changing requirements.
Employee may be required to lift objects up to 25lbs

Nice To Haves

Coaching
Consistency
Controls Compliance
Critical Thinking
Data Savvy
Engineering
Financial Competence
Good Automated Manufacturing Practice (GAMP)
ISO 9001
Lean Supply Chain Management
Leverages Information
Process Improvements
Quality Control (QC)
Quality Standards
Quality Systems Documentation
Quality Validation
Science, Technology, Engineering, and Math (STEM) Application
Technologically Savvy

Responsibilities

Ensures Actively participate in Design Control activities such as:
Lead Microbiology and Sterilization related activities: Establish validated sterilization cycle and ongoing process controls.
Assess sterilization cycle for adoption to other product families.
Perform assessment of sterile barrier and packaging controls to ensure integrity of validated sterilization cycle.
Identify appropriate microbiology test criteria for in process and final product testing (e.g. pyrogen, bacteriostasis/fungi stasis and bioburden) and establish ongoing process controls as part of Design Transfer.
Identify and qualify suppliers and complete testing per approved protocols.
Based on assessment or test results, establish relevant limits to ensure microbiology parameters are tracked and trended
Ensure test methods used as part of Design Controls are validated.
Subject Matter Expert on application of relevant standards, test sample sizes and usage of statistical techniques for new Design and Development Projects.
Identify testing and analysis required for the finished device to ensure conformance to product and user specifications.
Participate in FMEA meetings to ensure risks related to Microbiology are managed accordingly.
Provide support to Supplier Quality
Assist with qualifying and auditing suppliers related to sterilization, microbiology testing, Janitorial services, and CER monitoring.
Assist with managing/monitoring critical suppliers/ contract manufacturers for various SWMI business units.
Provide support to sustaining activities.
Support qualification and maintenance of CERs
Ensure CER monitoring is performed on a routine basis.
Collaborate with cross-functional teams, manage sample collection, coordinate with external suppliers, and ensure periodic sterilization monitoring activities are performed on a routine basis (e.g. quarterly dose audits, sterilization revalidation)
Track, trend and analyze results and publish periodic reports to demonstrate compliance with established procedures.
Undertake corrective actions to address non conformances.
Lead Microbiology audits.
Coordinate with Regulatory/Notified bodies to plan, coordinate, and conduct microbiology audits across different SWMI business units.
Undertake corrective actions and address non-conformances in compliant and timely manner.
Develop and maintain robust Quality Management System as it relates to Microbiology testing.
Review, investigate, disposition, and drive to completion Non-conforming Reports (NCR), Audit Findings and Corrective and Preventive Actions (CAPA).
Analyze and review data for key Quality metrics to identify any significant trends.
Initiate, review, and approve Document Change Orders (DCO).
Drive Standard Gaps Assessment activities.
Support ongoing Regulatory submission activities and product approval processes.
Participate in the implementation and continuous improvement of the Quality Management System.
J&J Credo: Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in dayto-day interactions with team.
Other duties as assigned

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits