Manager Quality Engineering – Lab and Computerized System Validation

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Geel, Antwerp, Belgium

Job Description

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for a Manager Quality Engineering – Lab and Computerized System Validation within a QA dept in Geel, Belgium. As a Manager Quality Engineering – Lab and Computerized System Validation: Within the Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Manager Quality Engineering (M/F/X). You will be a member of our quality engineering team, ensuring quality management and governance for Lab Systems, Automation Systems and IT Systems related to manufacturing of Active Pharmaceutical Ingredients and Drug Product Intermediates at the Innovative Medicine Supply Chain site in Geel, Belgium. You will be part of an enthusiastic team, and leading a sub team, that has a strong focus on technology, quality, compliance, and continuous improvement. Employees are very valuable to our organization and development is a daily responsibility. Through on the job training, e-learning, implementation of various projects and programs we ensure personal growth by focusing on your talents. We offer you a contract of indefinite duration with an attractive salary package including extra-legal benefits such as meal vouchers, additional pension plan and hospitalization insurance.

Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of APIs and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. Innovative Medicine Supply Chain Quality (IMSCQ) supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of APIs and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.

Responsibilities and the impact YOU will have

• QA Qualification and CSV Operational activities: Assuring that the qualification/CSV status is maintained during the life cycle of the systems in scope.
• Review and approval of qualification/CSV documents, Periodic System Quality Reviews, Validation Master Plans, Periodic Trend reports, calibration procedures and records, maintenance procedures and records.
• Participate in system introduction and system change projects and assure quality and compliance aspects.
• Prepare for regulatory and customer inspections and act as a spokesperson for QA qualification/CSV related matters during audits.
• Ensuring that deviations related to systems (qualification/CSV, maintenance, calibration and/or use) with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and preventive actions are implemented.
• Pro-actively and continuously challenge the quality of the qualification/CSV processes to improve the performance of qualification/CSV and develop and implement improvements.
• Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification/CSV.

Essential requirements

• Master scientific degree or equivalent experience.
• 5-10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.
• Fluent in Dutch and English (written and spoken).
• Thorough knowledge of cGMP regulations and guidelines in the area of qualification/CSV.
• Knowledge of GMP systems landscape: Lab systems and IT & Automation Systems used during the manufacturing processes.
• Strong analytical thinking, risk assessment, communication, managerial an