.Job Title: Manufacturing Quality EngineerDepartment: QualityReports To: Senior Manufacturing SupervisorClosing Date: 17th SeptemberJanssen Biologics B., 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.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. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.Responsibilities:Execute and support tasks that are typically not routine.Organize quality activities associated with team deliverables.Take ownership of non-conformance and/or change control records.Conduct thorough investigations into root causes and propose CAPA plans 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.Escalate issues and risks as required.Understand and comply with the Code of Business Conduct, Company policies, and laws that govern activities.Perform related duties as assigned by the supervisor.Apply in-depth knowledge of quality requirements to support the execution of organizational objectives.Review 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.Implement risk mitigations and continuous improvement projects.Update procedures based on new or revised regulatory requirements, internal investigations, and audits.Assist with formal customer concern processes.Take ownership of personal training and ensure timely completion.Improve a culture of belonging through inclusive relationships.If applicable, be the subject matter expert on deviations and/or change controls during inspections and audits.Qualifications: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.Intermediate level for MS Office, routine level for data analysis, and specialist level for business applications.Positive attitude, proactive, organized, with the ability to work individually and in a team.Must be able to work independently with minimum supervision
