Associate Maintenance Engineer, Quality

at  Johnson Johnson

Janssen Biologics BV, part of Johnson & Johnson Innovative Medicine, is recruiting for an associate maintenance engineer - Quality, to be located in Leiden, Netherlands.
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/.
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 meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster 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.
Janssen Biologics Leiden’s Make Asset Management (MAM) team is responsible for Life Cycle Management of manufacturing and utilities assets. The MAM team has three key functions: Execution Systems (Automation), Engineering and Maintenance.
Maintenance is responsible for maintaining the reliability of manufacturing assets and utilities, through preventive and corrective workorders. The Maintenance team consists of Supervisors, Technicians, Engineers and Specialists, partly working in 24/7 shifts. Due to expansion, we are currently looking for an Associate Maintenance Engineer - Quality.
If you like to interact with people, are enthusiastic, curious, quality-oriented and want to play a crucial role in f.i. the investigation and prevention of non-conformances related to Maintenance, then we are looking for you!
Responsibilities:
As the Associate Maintenance Engineer – Quality, you execute and support others with tasks that are typically not routine. Organize quality activities associated with team deliverables. Take the ownership of non-conformance and/or change control records. Are responsible for a thorough investigation into the root cause and proposes a CAPA plan to prevent recurrence. Demonstrate 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.

Specific tasks are:

• Non-Conformance Coordination: initiate non-conformances in Comet and coordinates that the correct information is provided from the various disciplines (MAM, Operations, QC, etc.). You maintain contact with QA and monitors that records are closed in a timely manne and facilitate Root Cause Analyzes and Event Mapping.
• CAPA Coordination: encourages the responsible CAPA lead to provide the information in a timely manner and assists with correct reporting in Comet. The administrative actions surrounding CAPAs (such as creating and closing records) are also done by the Associate Maintenance Engineer - Quality.
• Change Control Coordination: translates the need for a change into a technically sound compliance story and assists the MAM organization with changes through expertise and administrative actions.
• Notification assessments: provides an assessment for all notifications and, if necessary, obtains the correct information from the various disciplines. You are the first point of contact for questions from QA.
• Final quality review of job orders: After job orders have been closed, you carry out the final assessment in accordance with underlying procedures.
• Truvault: coordinates the document routing for new or existing procedures, work instructions, reports etc
• Training: assists with periodic reviews of curriculum content and the correct linking of people to the correct trainings.

QUALIFICATIONS

• At least a relevant MBO-4 diploma with 3 years validated experience in (bio)pharmaceutical industry or Engineering and Technical subjects (electrical, instrumentation or mechanical)
• Good verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent computer proficiency e.g. MS Office, SAP
• 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.
  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, in the Netherlands, are working to create an inclusive environment where a diverse set of 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.
  Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”

• Non-Conformance Coordination: initiate non-conformances in Comet and coordinates that the correct information is provided from the various disciplines (MAM, Operations, QC, etc.). You maintain contact with QA and monitors that records are closed in a timely manne and facilitate Root Cause Analyzes and Event Mapping.
• CAPA Coordination: encourages the responsible CAPA lead to provide the information in a timely manner and assists with correct reporting in Comet. The administrative actions surrounding CAPAs (such as creating and closing records) are also done by the Associate Maintenance Engineer - Quality.
• Change Control Coordination: translates the need for a change into a technically sound compliance story and assists the MAM organization with changes through expertise and administrative actions.
• Notification assessments: provides an assessment for all notifications and, if necessary, obtains the correct information from the various disciplines. You are the first point of contact for questions from QA.
• Final quality review of job orders: After job orders have been closed, you carry out the final assessment in accordance with underlying procedures.
• Truvault: coordinates the document routing for new or existing procedures, work instructions, reports etc
• Training: assists with periodic reviews of curriculum content and the correct linking of people to the correct trainings