Medical Writing vacatures

Staff Scientist, Microbiological Quality & Sterility Assurance (MQSA)

• Location: Groningen

• Duration of the contract: 6 months (possible extension)

• Hours per week: 40

Imagine your next project leading the end-to-end execution of sterility assurance strategies for revolutionary vision care products that impact millions of patients globally. As a Staff Scientist MQSA, you will act as the global technical authority driving contamination control, sterilization validation, and microbiological quality across global operations.

roles and responsibilities

You will be responsible for the end-to-end execution of microbiological quality and sterility assurance strategies and policies across J&J Vision.

This will involve:

• Serves as a core team member for NPI, collaborating on modality selection, business case formulation, and protocol/report writing while liaising with Regulatory Affairs.

• Leads on-site validation for new contract sterilization sites (visits, cycle development, process characterization, validations, and regulatory support).

• Collaborates on innovative contamination control and terminal sterilization solutions with academic and industry experts.

• Manages the lifecycle of aseptic processing, microbiological, and/or sterilization processes for the J&J Vision product portfolio.

• Owns and drives test method development, validations, and transfers as a Subject Matter Expert (SME), including protocol and report approval.

• Conducts site audits to ensure compliance, supports post-audit corrective actions, and assists in designing new manufacturing processes and controlled environments.

• Supports on-site external and internal regulatory audit visits, presenting to auditors and supporting post-audit corrective actions (CAPA).

how to succeed

You are a seasoned microbiology and sterilization expert who thrives in a fast-paced, highly regulated global matrix environment, bringing a strong scientific approach to risk assessment and troubleshooting.

You will also bring:

• At least 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 (e.g., Gas and heat processes, aseptic processing, radiation).

• Minimum: Bachelor's degree in Microbiology, Biology, Engineering, or a related discipline.

• Ability to work onsite a minimum of 3 days per week in Groningen and willingness to travel up to 50%.

• Prior experience interacting with regulatory authorities and conducting technical assessments is preferred.

• Advanced degrees (MS or PhD) are preferred.

• Strong capability to lead and mentor a diverse, multinational practice community.

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months (possible extension).

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Vision

Johnson & Johnson Vision brings together cutting-edge insights, science, technology and people. We partner with eye care professionals and help more people around the world preserve and restore sight. Our portfolio includes the best selling contact lens brand in the world, ACUVUE®, plus consumer eye health solutions, dry eye treatments, refractive (Lasik) and cataract products. Contribute to the next healthcare breakthrough, create a world connected by SIGHT™ with your next project at Johnson & Johnson Vision.

application process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.