GMP Specialist / Quality Engineer

GMP Specialist / Quality Engineer 

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

Duration: 12 months

Hours: Full time

The Lenti Viral Vector Facility: Janssen Biologics B.V., part of Johnson & Johnson, is setting up a new production facility in Sassenheim. This new facility will produce lentiviral vector (LVV), which is used in the treatment for multiple myeloma, a disease affecting 160.000 patients globally. The project team is preparing to get ready for commercial production in 2025.

We are searching for the best talent for a GMP Specialist to be in Sassenheim, Netherlands.

The GMP specialist is responsible for GMP related items in BU5 and supports the BU5 organization with specialized and in-depth knowledge and skills on the GMP processes, systems and compliance. This role requires the ability to devise effective solutions while collaborating and aligning with various stakeholders.

The GMP Specialists are integral members of the broader Centre of Expertise (CoE) department. The CoE is crucial in supporting both the Operations (Ops) and New Product Introduction (NPI) departments, particularly regarding technical processes and GMP compliance (including Annex 1).The CoE plays a key role in translating the developed process to a workable process and environment for the shop floor. The CoE always works against the high-quality standards, safety and compliance regulations that are applicable for LVV manufacturing.

roles and responsibilities

• Leads deviations and root cause investigations and ensures a timely follow up and completion of the non-conformance records. 

• Write and facilitate change controls to document introductions and changes in the GMP production processes.

• Review general LVV GMP documentation and delegate improvements to keep the general GMP compliance up to date. 

• Participating/facilitate in quality risk assessments (QRA).

• Coordinating, supporting and preparing activities during internal and external audits in the role of Primary Contact, SME, scribe, or back-office lead.

• Coordinator internal batch release.

how to succeed

• Bachelor or University degree in preferably Science or Engineering.

• 2-8 years’ experience in a biotechnology or biopharmaceutical (GMP) production environment.

• Strong working knowledge of current Good Manufacturing Practice (cGMP) standards is essential. Familiarity with Annex 1 regulations is preferred. Experience with the use quality systems (E.g. Comet, TruVault).

• Experience with the following Microsoft tools: Excel, Visio, SharePoint, Word and PowerPoint.

• Excellent communication skills in English, additional Dutch is preferred.

• Influencing skills, excellent stakeholder management within a high complex matrix organization

At Janssen Biologic B.V., we are driven by our commitment to innovative medicine and the patients we serve. As a GMP Specialist, you will play a pivotal role in ensuring the highest standards of quality and compliance in our cutting-edge therapies. If you are passionate about science and eager to contribute to meaningful healthcare advancements, we invite you to apply.

Embrace the opportunity to be part of a team that transforms lives through groundbreaking medical solutions. Together, let’s champion the journey from lab to life and make a lasting impact on the world!

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

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. 

The pay rate for this role will depend on how you are paid. 

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”.