Johnson & Johnson
Engineer
Engineer MSAT Validation - Biotherapeutics Drug Substance
Location: Leiden
Working mode: Hybrid, 3 days on-site and 2 WFH
Language requirements: English proficiency required; Dutch is plus.
Duration: 6 months
Hours: Full-time, 40 hours per week
J&J Innovative Medicine, a member of the Johnson & Johnson Family of Companies is recruiting for a 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.
The Engineer Validation is a member of the MSAT SPV (Supporting Process Validation) Team with the dedicated focus on:
Validation of supporting processes (e.g. sterilization, mixing validation, buffer and microbial hold time).
Process improvements, benchmarking and standardization.
New technology deployment.
roles and responsibilities
Plan and coordinate execution of SPV activities such as qualification of mixing, buffer hold time, microbial hold time and 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
Education
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.
Experience and Skills
Required
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. sterilization, mixing validation, buffer and microbial hold time) and related regulatory requirements and industry guidelines specific for 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.
Preferred
Experience in mixing validation, buffer and microbial hold time, sterilization (moist heat) qualification.
6-Sigma/Lean or similar continuous improvement methodology experience.
benefits
This role offers a very competitive hourly rate. This contract will initially run for 6 months.
you are welcome here
Johnson & Johnson Innovative Medicine 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”.