Validation Engineer MSAT

Validation Engineer MSAT Advanced Therapies

Location: Sassenheim - Hybrid working - 3 days on site

Duration: 12 month contract

Hours: 40 Hours

Imagine your next project supporting Validation of supporting processes (e.g. Mixing, Sterilisation, Bio-decontamination, Aseptic Process simulation, airflow visualization pattern), process improvements and standardisation and/or technology implementation projects. This role is open to freelancers.

The Validation Engineer MSAT Advanced Therapies is responsible for supporting Validation of supporting processes (e.g. Mixing, Sterilisation, Bio-decontamination, Aseptic Process simulation, airflow visualisation pattern), process improvements and standardisation and/or technology implementation projects. The Engineer Validation MSAT Advanced Therapies acts as Subject Matter Expert in one or more validation categories.

roles and responsibilities.

The Senior Engineer Validation MSAT Advanced Therapies is responsible for supporting Validation of supporting processes, process improvements and standardisation and/or technology implementation projects.

This will involve:

• Lead the execution of validation activities such as Bio-decontamination qualification, Aseptic process simulation, mixing validation, bio-decontamination, aseptic process simulation, and airflow visualization pattern.

• Write and review validation plans, protocols and reports.

• Communicate with stakeholders to coordinate timing of execution, provide status updates, and escalate issues.

• Act as Project Core Team Member for medium sized projects and as such:

  • Define validation strategy.

  • Represent MSAT in multidisciplinary team and align with extended team members.

  • Plan and deliver team/project Goals and Objectives.

  • Manage timelines and communicate project status.

  • Provide direct input to resource planning.

• Act as SME for one or more validation categories.

• Leverage global MSAT network to identify and implement industry best practices.

• Participate in preparation and represent MSAT in audits/inspections

• Perform Change Control assessments and execute against assigned actions.

• Act as coach for more junior engineers.

• Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo etc.)

how to succeed.

To succeed in this role, you will bring knowledge of scientific or technical core area and building knowledge and experience in other technical and business disciplines, coupled with proven experience in GMP and Quality Compliance, and capability of delivering local small projects, regional project work streams or departmental programs successfully under strong supervision.

You will also bring:

• Knowledge of and experience in a scientific or technical core area and building knowledge and experience in other technical and business disciplines.

• Proven experience with GMP and Quality Compliance.

• Precise, accurate, structured, flexible and customer focused.

• Capable of delivering local small projects, regional project work streams or departmental programs successfully under strong supervision.

• Bachelor’s degree in a Science, Engineering or Technical subject and minimum 4 years of relevant experience in the (bio)pharmaceutical industry or related post graduate academic experience/education is required.

• Fluent in written and spoken English.

benefits.

This role offers a very competitive hourly rate. This contract will run for 12 month contract

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 Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

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”.