Staff Scientist, Microbiological Quality & Sterility Assurance Full-time NEW

Staff Scientist, Microbiological Quality & Sterility Assurance

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.

The Staff Scientist, Microbiological Quality & Sterility Assurance (MQSA) at Johnson & Johnson Vision is responsible for the end-to-end execution of microbiological quality and sterility assurance strategies and policies. These responsibilities will align with the strategic priorities of Johnson & Johnson's microbiological sterility assurance initiatives.

In this role, the Staff Scientist will support the global technical leader in areas including New Product Introductions (NPI), Method/Product Validations/Transfers, Regulatory Affairs Support, aseptic processing, sterilization, and microbiological quality across all Johnson & Johnson Vision locations worldwide. This individual will oversee the implementation of company policies concerning cleanliness, aseptic processing, sterilization, clean rooms, water systems, and microbiological quality.

This individual will be responsible for activities such as, but not limited to, the following:

• Serve as a core team member for NPI, collaborating on modality selection, business case formulation, and protocol/report writing while liaising with Regulatory Affairs for submission requirements.
• Lead on-site validation for new contract sterilization sites, which includes conducting visits, cycle development, process characterization, validations, and providing regulatory support.
• Collaborate on innovative contamination control and terminal sterilization solutions, engaging with academic and industry experts.
• Work closely with Technical Vertical MQSA Leaders to explore groundbreaking technologies that support future growth.
• Support defining packaging requirements for terminal sterilization/aseptic processing, participating in review and approval of relevant protocols and reports.
• Partner with biocompatibility and chemistry teams to evaluate the impacts of sterilization on product requirements.
• Life cycle management of aseptic processing, microbiological and/or sterilization process for product portfolio within Johnson & Johnson Vision.

Job Qualifications:

• Extensive experience in microbiology, sterilization validation (terminal, aseptic, reprocessing), and environmental control practices within medical device manufacturing.
• Proven expertise in multiple sterilization methodologies (e.g., Gas and heat processes, aseptic processing, radiation).
• Strong capability to lead and mentor a diverse, multinational practice community.
• Prior experience interacting with regulatory authorities and conducting technical assessments is preferred.
• Successful track record in troubleshooting issues related to microbiological and sterilization processes with effective CAPA implementation.
• High knowledge of global external standards and the ability to represent the company at industry associations.
• Excellent communication skills, with the ability to effectively engage with various stakeholders.
• Strong organizational and time management skills, coupled with a collaborative approach to teamwork.
• Team player with a customer focus is required.

Required Education and Experience:

• A minimum of a Bachelor's degree in Microbiology, Biology, Engineering, or a related discipline; advanced degrees (MS or PhD) are preferred.
• At least 8 years of experience in the medical device or pharmaceutical industry in a GMP and/or ISO regulated environment.
• Proficient in software tools including Excel, Word, PowerPoint, and analytical software applications.

Supervisor: This position will report directly to the Director, Johnson & Johnson Microbiological Quality & Sterility Assurance.

Work Environment: This role requires a minimum of 3 days per week onsite and will involve regular interaction with aseptic processing and manufacturing facilities. Travel to other sites/EMs for onsite support is a requirement. The individual must be able to comply with established safety procedures and policies to maintain a safe working environment to ensure compliance with Johnson & Johnson environmental policies.

Organization: J&J Vision

Travel: Yes, 50%

Job Function: Quality

Required Skills: Accelerating, Agility Jumps, Coaching, Communication, Compliance Management, Continuous Improvement, Data Savvy, Disaster Recovery (DR), Econometric Models, Issue Escalation, Problem Solving, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Researching

The anticipated base pay range for this position is: €64,000.00 – €103,040.00

Benefits: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees – and in some location's eligible dependents – can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.