Description
Job Title: Manufacturing Quality Engineer
Department: Quality
Reports To: Senior Manufacturing Supervisor
Closing Date: 17th September
Janssen Biologics B.V. , a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where sophisticated 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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver significant solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we cultivate a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Manufacturing Quality Engineer
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!
Responsibilities that YOU have:
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 and/or change control 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.
- Is required to understand and comply with the Code of Business Conduct, Company policies and laws that govern their activities.
- Perform 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).
- Reviews documentation associated with processes and activities for the Operations unit.
- Ensure compliant documentation and accurate completion of quality records.
- 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 mentorship.
- Updates procedures based on new or revised regulatory requirements, internal investigations, and audits.
- Assists with formal customer concern 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.
- Improve a culture of belonging through unquestioning, divers, and inclusive relationships.
- If applicable, be the subject matter expect on deviations and / or change controls during inspections and audits.
Qualifications
We would love to hear from YOU, if you have the following essential requirements:
- At least a relevant MBO-4 diploma with 3 years validated experience in the (bio)pharmaceutical industry.
- Good communication skills, written and verbal in Dutch A2 and English B2 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, crucial, 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 creatively) to develop a solution.
- Stress-resistant, continues to work calmly under all circumstances.
- Flexible, can deal with changing priorities.
- Previous experience with leading quality investigations and/or change controls.
This is what awaits YOU at J&J:
- Competitive salary and extended benefits package.
- A safe and controlled work environment crafted to support high-quality workmanship and compliance with industry standards.
- Comprehensive training with an assigned buddy.
- Opportunity to work with a dedicated and hardworking team.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.