Manager Quality Engineering – Facilities Utilities Equipment

Biopharma Careers; Geel; Sur place; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Healthcare coverage

Résumé du poste

Johnson & Johnson in Geel, Belgium, is recruiting a Manager Quality Engineering – Facilities Utilities Equipment within a QA department. You will lead QA qualification activities for facilities, utilities, and production equipment used for APIs and DP Intermediates at the Geel site.

You will manage a QA qualification team, oversee resources and budget, and ensure compliance with cGMP and regulatory requirements, while driving continuous improvements and professional development opportunities.

Qualifications

• Master scientific degree or equivalent experience.
• 5-10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.
• Thorough knowledge of cGMP regulations and guidelines in the area of qualification.
• Knowledge of the different systems used during the manufacturing process.
• Strong analytical thinking, risk assessment, communication, managerial and leadership skills.
• Collaboration and teaming skills.
• Mindset for innovation and optimization.
• Fluent in Dutch and English (written and spoken).

Responsabilités

• QA Qualification Operational activities: maintaining qualification status during system life cycle.
• Review and approve qualification documents, PQPs and calibration records.
• Participate in system introduction and system change projects with quality and compliance focus.
• Prepare for regulatory inspections and act as QA qualification spokesperson.
• Evaluate deviations related to systems and implement CAPAs.
• Continuously improve qualification processes and pursue best practices.
• Maintain current knowledge of international regulations and industry practices.

Connaissances

GMP

ISO 9001

QMS

SOP

Regulatory

Quality Validation

Quality Management

Process Improvements

Continuous Improvement

Formation

Master scientific degree

Description du poste

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 – Facilities Utilities Equipment within a QA dept in Geel, Belgium.

As a Manager Quality Engineering – Facilities Utilities Equipment:

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 Facilities, Utilities and Production Equipment 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 team, to manage resources and budget and follow up on key performance indicators.

The main responsibility is to ensure compliance of qualification activities of Facility, Utilities and Production Equipment. This includes system qualification documentation, calibration & maintenance documentation, change controls, non-conformances.

The responsibilities and the impact YOU will have:

QA Qualification Operational activities:

• Assuring that the qualification status is maintained during the life cycle of the systems in scope.
• Review and approval of qualification 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 related matters during audits.
• Ensuring that deviations related to systems (qualification, 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 processes to improve the performance of qualification and develop and implement improvements.
• Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification.

We would love to hear from YOU, if you have the following essential requirements:

• Master scientific degree or equivalent experience.
• 5-10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.
• Thorough knowledge of cGMP regulations and guidelines in the area of qualification.
• Knowledge of the different systems used during the manufacturing process.
• Strong analytical thinking, risk assessment, communication, managerial and leadership skills.
• Collaboration and teaming skills.
• Mindset for innovation and optimization.
• Fluent in Dutch and English (written and spoken).

This is what awaits YOU at J&J:

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 andprofessional development/education.
• Excellentbenefits.

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.

Required Skills:

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

Preferred Skills:

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

The anticipated base pay range for this position is:€79,800.00 - €137,770.00

Benefits:

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.