Quality Engineer

Quality Engineer

Location: Leiden -  Einsteinweg

Duration: 6 months

Hours: 40 - on-site

We are looking for a Manufacturing Quality Engineer for our Biotherapeutics Operations Upstream Center of Expertise Quality team.  The Biotherapeutics Operations department is responsible for the production of biotherapeutic drug substances.

If you like to interact with people, are enthusiastic, curious, quality-oriented and want to play a crucial role in the investigation and prevention of non-conformances related to the Operations Primary Recovery department, then we are looking for you to support our team!

roles and 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.

how to succeed

• At least a relevant MBO-4 diploma with 3 years relevant experience in the (bio)pharmaceutical industry. 

• Good communication skills, written and verbal in Dutch and English language levels are required.

• 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.

This is what awaits YOU at J&J:

• A safe and controlled work environment designed to support high-quality workmanship and compliance with industry standards.

• Comprehensive training with an assigned buddy.

• Opportunity to work with a dedicated and enthusiastic team.

details

This role offers a very competitive hourly rate. 

This contract will run for a 6 month period. 

On-site position 

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at 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. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

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”.