Manager Quality Engineering – Lab and Computerized System Validation
Johnson & Johnson Innovative Medicine
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Résumé du poste
Johnson & Johnson Innovative Medicine seeks a Manager Quality Engineering – Lab and Computerized System Validation in Geel, Belgium. You will lead the QA Qualification/CSV team, ensuring quality governance for Lab, Automation, and IT systems used in API and DP Intermediates manufacturing within the IM site.
You will manage resources, budget, and KPIs, drive compliance, and prepare for inspections. The role offers an international, purpose-driven environment with development and strong benefits.
Qualifications
- 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.
- Knowledge of GMP systems landscape: Lab systems and IT & Automation Systems.
- Strong analytical thinking, risk assessment, communication, managerial and leadership skills.
- Collaboration and teaming skills.
- Mindset for innovation and optimization.
Responsabilités
- 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.
- 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 and develop improvements.
- Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification/CSV.
Connaissances
Formation
Description du poste
- Excellent benefits.
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.
Quality
Quality Assurance
Professional
Geel, Antwerp, Belgium
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
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.
As Manager Quality Engineering you are responsible to lead and coach the QA Qualification/CSV team, to manage resources and budget and follow up on key performance indicators.
The main responsibility is to ensure compliance of qualification and CSV activities of Lab Systems, Manufacturing Automation Systems and IT Systems. This includes system qualification and Computer System Validation documentation, calibration & maintenance documentation, change controls, non-conformances,…
- 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.
- 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 and leadership skills.
- Collaboration and teaming skills.
- Mindset for innovation and optimization
This is an opportunity to work with a ground-breaking biomedicine operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.
Whether you’re one of the people who already work here, or you’re considering joining the team, we offer:
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Opportunities to work on challenging projects and assignments.
- Possibilities for further personal and professional development/education
- Excellent benefits.
Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.
- Business Alignment
- Coaching
- Collaboration
- Compliance Management
- Continuous Improvement
- Fact-Based Decision Making
- Good Manufacturing Practices (GMP)
- ISO 9001
- Process Improvements
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Quality Validation
- Regulatory Environment
- Standard Operating Procedure (SOP)
- Tactical Thinking
- Technical Credibility
€79,800.00 - €137,770.00
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
- This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
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