Senior MSAT Engineer

Senior Engineer MSAT Validation

Location: Leiden, the Netherlands

Duration: 1 year

Hours:40

Imagine your next project contributing to life-changing science at a company that is creating the next generation of biotherapeutic drug substances.

Roles and Responsibilities

This role is a member of the Manufacturing Science & Technology (MSAT) Supporting Process Validation (SPV) Team with a dedicated focus on:

• Validation of supporting processes (e.g., cleaning, mixing, sterilization, holding time).

• Process improvements, benchmarking, and standardization.

• New technology deployment.

This will involve:

• Leading, planning, coordinating, and executing validation activities such as cleaning validation, mixing validation, sterilization qualification, and holding time studies.

• Supporting the definition of validation strategy and change control assessments.

• Writing, reviewing, and approving validation protocols and reports.

• Supporting projects as an extended project team member responsible for validation activities, providing regular status updates in a timely manner.

• Communicating with stakeholders to coordinate timing of execution and escalating issues.

• Supporting the execution of activities for audit/inspection readiness.

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

How to Succeed

• You will bring a Bachelor’s or master’s degree or equivalent in Science, Engineering, or a Technical subject with a minimum of 4 years of relevant experience in the (bio)pharmaceutical industry or related academic experience or education. 

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

• An understanding of regulatory requirements and industry guidelines specific to the pharmaceutical industry and validation (e.g., FDA, EMA, ICH, ASTM, ISO, ISPE, PDA).

• Experience in qualification and validation (e.g., cleaning validation, mixing validation, sterilization qualification, holding time studies).

Benefits

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

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.