Engineer MSAT Validation

Engineer MSAT Validation

Location: Leiden, Netherlands - Hybrid working 3 days a week on site

Duration: 12 months

Hours: 40 hours per week

Imagine your next project working as a member of the MSAT Supporting Process Validation (SPV) Team where you will be a key driver of sophisticated technologies to enable the best value for patients at a site producing biotherapeutic drug substances.

J&J Innovative Medicine, a member of the Johnson & Johnson Family of Companies is recruiting for an Engineer MSAT to be based in Leiden, the Netherlands. 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 key driver of sophisticated technologies to enable the best value for patients.

The Engineer is a member of the MSAT Supporting Process Validation (SPV) Team with the dedicated focus on: Validation of supporting processes (e.g., cleaning, mixing, sterilization, holding time). Process improvements, benchmarking, and standardization. New technology deployment.

roles and responsibilities.

• Plan, coordinate, and execute manufacturing equipment validation activities such as cleaning validation, mixing validation, and hold time studies.

• Write and review validation protocols and reports.

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

• Communicate with stakeholders to coordinate timing of execution and escalate issues.

• Support execution of activities for audit/inspection readiness.

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

how to succeed.

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

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

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

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

Preferred.

• Experience or knowledge in validation of manufacturing equipment (e.g., cleaning process, mixing process, microbial/ chemical holding time studies).

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

benefits.

This role offers a very competitive hourly rate. This contract will run for 12 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 or LinkedIn InMail - you must apply direct to this advert.

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”.