MSAT Validation Engineer

MSAT Validation Engineer

• Location: Leiden, Netherlands

• Duration of the contract: 6 months

• Hours per week: 40 hours

Imagine your next project driving technical process validation to ensure the flawless production of life-saving biotherapeutics for patients worldwide.

J&J Innovative Medicine, a member of the Johnson & Johnson Family of Companies is recruiting for an Engineer MSAT Validation to be based in Leiden, the Netherlands. Our site produces biotherapeutic drug substance and is growing our portfolio with the introduction of new clinical and commercial products.

The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation (SPV), technical product ownership and key driver of sophisticated technologies to enable the best value for patients.

roles and responsibilities 

As a member of the MSAT SPV (Supporting Process Validation) Team, you will focus on the validation of supporting processes, process improvements, benchmarking, and standardization.

This will involve:

• Plan and coordinate execution of Supporting Process Validation (SPV) activities such as qualification of mixing, buffer hold time, microbial hold time and moist heat sterilization processes.

• Write and review validation documents (e.g. protocols and reports).

• Support projects as an extended team member responsible for performance qualification activities providing regular status updates in a timely manner.

• Execute performance qualification activities to support the site change control program.

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

how to succeed 

You are an analytical and detail-oriented engineering or biotechnology professional who thrives in a regulated GMP environment, bringing strong foundational knowledge of validation guidelines and documentation practices.

You will also bring:

• A relevant MS/MBA (e.g. (Bio)Chemical Engineering, Biotechnology) with 0-2 years of relevant experience OR bachelor’s degree with 2+ years of relevant experience.

• Relevant experience in the (bio)pharmaceutical industry or related academic experience or education.

• Experience with GMP, following data integrity principles (e.g., ALCOA+) ensuring proper documentation.

• Knowledge of validation and qualification (e.g. moist heat sterilization, mixing validation, buffer and microbial hold time) and related regulatory requirements and industry guidelines specific to the pharmaceutical industry (e.g. FDA, EMA, WHO, ISO, ICH, ISPE, PDA).

• Skills in effective communication, planning, documentation practices, risk management, root cause problem solving and knowledge management.

• Experience in mixing validation, buffer and microbial hold time, sterilization (moist heat) qualification.

• 6-Sigma/Lean or similar continuous improvement methodology experience.

• English proficiency required; Dutch is a plus.

benefits 

This role offers a very competitive hourly rate. This contract will run for 6 months.

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.

questions 

If you have any questions regarding this position or the recruitment workflow, please ensure they are submitted directly through our official application channels.

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”.