Staff Scientist, Microbiological Quality & Sterility Assurance (MQSA)
Role Overview
We are looking for an experienced Staff Scientist, Microbiological Quality & Sterility Assurance (MQSA) to support the end-to-end execution of sterility assurance strategies for revolutionary vision care products that impact millions of patients globally.
In this role, you will act as the global technical authority driving contamination control, sterilization validation, and microbiological quality across global operations. You will work within a highly regulated environment, collaborating with cross-functional stakeholders to ensure compliance, support innovation, and maintain the highest standards of microbiological quality and sterility assurance across the product portfolio.
Key Responsibilities
- You will be responsible for the end-to-end execution of microbiological quality and sterility assurance strategies and policies across J&J Vision.
- Serve as a core team member for NPI, collaborating on modality selection, business case formulation, and protocol/report writing while liaising with Regulatory Affairs.
- Lead on-site validation for new contract sterilization sites, including visits, cycle development, process characterization, validations, and regulatory support.
- Collaborate on innovative contamination control and terminal sterilization solutions with academic and industry experts.
- Manage the lifecycle of aseptic processing, microbiological, and/or sterilization processes for the J&J Vision product portfolio.
- Own and drive test method development, validations, and transfers as a Subject Matter Expert (SME), including protocol and report approval.
- Conduct site audits to ensure compliance, support post-audit corrective actions, and assist in designing new manufacturing processes and controlled environments.
- Support on-site external and internal regulatory audit visits, presenting to auditors and supporting post-audit corrective actions (CAPA).
Requirements
Must Have
- Minimum 8 years of experience in the medical device or pharmaceutical industry in a GMP and/or ISO regulated environment.
- Extensive experience in microbiology, sterilization validation (terminal, aseptic, reprocessing), and environmental control practices.
- Proven expertise in multiple sterilization methodologies, including gas and heat processes, aseptic processing, and radiation.
- Bachelor's degree in Microbiology, Biology, Engineering, or a related discipline.
- Strong scientific approach to risk assessment and troubleshooting.
- Ability to thrive in a fast-paced, highly regulated global matrix environment.
- Strong capability to lead and mentor a diverse, multinational practice community.
Nice to Have
- Prior experience interacting with regulatory authorities.
- Experience conducting technical assessments.
- Advanced degree (MS or PhD) in a relevant discipline.
- Previous experience supporting regulatory audits and inspections.
- Leadership experience within international, cross-functional teams.
Additional Information
- Contract: 6 months (possible extension)
- Location: Groningen, Netherlands
- Hours: 40 hours per week, 3 days min on site
- Travel: Up to 50%
Interested or know someone who could be a great fit?
Please send your CV or referral to e.cabral@panda-int.com.