MSAT Validation Engineer

Engineer MSAT Validation

Location: Leiden, the Netherlands

Duration: 12 months

Hours: 40

Imagine your next project: Our site produces biotherapeutic drug substances and is growing our portfolio. The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation, technical product ownership and a key driver of sophisticated technologies to enable the best value for patients.

Roles and Responsibilities

This will involve:

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

• Writing and reviewing 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 escalate 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 also bring:

• A Bachelor’s degree or equivalent in Science, Engineering, or a Technical subject.

• Minimum 2 years of relevant experience in the (bio)pharmaceutical industry or related academic experience or education.

• Skills in communication, planning, 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 or knowledge in validation (e.g., cleaning validation, mixing validation, sterilization qualification, holding time studies) (Preferred).

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

Benefits

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

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.