Quality Engineer

Quality Engineer

Location: Leiden 

Duration: initial 6 months contract

Hours: 40h

Hybrid role 

Imagine your next role as a Quality Engineer where you will play a crucial role in the investigation and prevention of non-conformances related to the Operations Primary Recovery department

About the department

The Biotherapeutics Operations department is responsible for the production of biotherapeutic drug substances.

Main Responsibilities

The Manufacturing Quality Engineer executes and supports others with tasks that are typically not routine. Organizes quality activities associated with team deliverables. Takes the ownership of non-conformance records. Is responsible for a thorough investigation into the root cause and proposes a CAPA plan to prevent recurrence. Demonstrates effective communication skills with both internal and external customers. Build a strong network within the organization to support and improve the quality of our processes and products. Escalates issues and risks as required. 

Specific tasks are:

• Demonstrates Johnson & Johnson’s Leadership Imperatives and Credo in day-to-day interactions with the team.

• Understands and complies with the Code of Business Conduct, Company policies and laws that govern their activities.

• Performs related duties as assigned by the supervisor.

• Applies in-depth knowledge of quality requirements to support the execution of organizational objectives (e.g., lead nonconformance investigations and root cause investigations, including CAPA records).

• Performs in-depth interviews in case of human related non-conformances.

• Reviews documentation associated with processes and activities for the Operations unit.

• Ensures compliant documentation and timely completion of quality records.

• May act as change control (CC) lead for Operations by being responsible for the change control from initiation through completion.

• Implements risk mitigations and continuous improvement projects, under limited guidance.

• Assists with formal escalation processes to ensure visibility of risks associated with safety, product quality and regulatory compliance.

• Takes ownership of personal training and ensures that all required training is understood and completed on time.

• Enhances a culture of belonging through trusting, divers, and inclusive relationships.

The ideal candidate for this position should have:

• At least a relevant MBO-4 diploma with relevant experience in the (bio)pharmaceutical industry. 

• Good communication skills, and fluent English.

• The levels of computer proficiency are intermediate level for MS office, routine level for data analysis, and specialist level for business applications.

• Positive attitude, proactive, decisive, and organized with an ability to work individually and in a team.

• Must be able to work independently with minimum supervision. It is important to plan your own tasks well.

• High degree of accuracy and a quality attitude.

• Analytical thinking: ability and dealing with complexity, asking questions, using data, using information, and identifying gaps and root causes of issues, and be innovative (be able to think outside the box) to develop a solution.

• Stress-resistant, continues to work calmly under all circumstances.

• Flexible, can deal with changing priorities.

• Previous experience with leading quality root-cause investigations.

benefits

This role offers a competitive hourly rate & a supportive working environment. This contract will run initially for 6 months. 

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

https://www.jnj.com/

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”.