QA - Manufacturing Equipment Qualification Engineer

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Leisure/Health benefits

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson is seeking a Manufacturing Equipment Qualification Engineer within the QA department in Geel, Belgium. You will oversee equipment qualification for SM-API and DP Intermediates, ensuring quality oversight across the production lifecycle and regulatory compliance within GMP frameworks.

You will collaborate with engineering, operations and cross-functional teams, drive audits, validation activities and continuous improvement while upholding cGMP standards and project timelines.

Qualifications

• Master scientific degree or equivalent experience.
• 4 - 6 years’ experience in pharmaceutical or chemical industry.
• Knowledge of cGMP/Qualification compliance (21 CFR Parts 211; EU Directive 2003/94/EC and annex 11/15; ICH Q7, GAMP, Data Integrity Guidelines…)
• Experience with Equipment Qualification.
• Fluent in verbal and written communication in English and Dutch.

Responsabilités

• Assure that Equipment Qualification related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase).
• Review and approve Qualification documents such as SOPs, user requirements, risks analysis, Qualification Plans, tests, changes, deviations etc. to maintain compliance to regulations and standards.
• Maintain knowledge of international laws, guidelines and evolutions related to Qualification and apply this to improve Equipment Qualification at J&J.
• Prepare for and be spokesperson in audits and inspections.
• Perform and follow up on internal and external audits to accomplish regulatory compliance.
• Cooperate with engineering, operations and other teams for new systems and processes.

Connaissances

English fluency

Dutch fluency

Quality mindset

Analytical thinking

GxP compliance

Audit readiness

Cross-functional collaboration

Project coordination

Formation

Master's degree or equivalent

Description du poste

Job Function: Supply Chain Engineering

Job Sub Function: Quality Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Geel, Antwerp, Belgium

Job Description:

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 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.

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 the best talent for a Manufacturing Equipment Qualification Engineer within a QA dept in Geel, Belgium. Quality Engineer – Manufacturing Equipment Qualification Engineer Within the Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Staff Quality Engineer (M/F/X). You will be a member of our quality engineering team, ensuring quality oversight for production equipment related to manufacturing of Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product Intermediates at the Innovative Medicine Supply Chain site in Geel, Belgium. You will be part of an enthusiastic team that has a strong quality focus on technology, qualification/validation, automation, 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 SM-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 SM-APIs and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations. As Staff Quality Engineer, you act as Subject Matter Expert ensuring quality oversight for production equipment.

• To assure that all Equipment Qualification related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase).
• Review and approve Qualification documents such as SOPs, user requirements, risks analysis’s, Qualification Plans, tests, changes, deviations etc…) in order to maintain compliance to regulations, guidelines, J&J policies and standards.
• Maintain a current knowledge of international laws, guidelines and new evolutions related to Qualification through courses, conferences, seminars, internal and external benchmarking and literature studies.
• Implement this knowledge to maintain and improve Equipment Qualification at J&J.
• Prepare for and be spokesperson in audits and inspections.
• Perform and follow up on internal and external audits to accomplish regulatory compliance.
• Cooperate with engineering, operations and other teams for the introduction of new systems and processes.
• To give advice and support for the preparation of Qualification related activities and guard the cGMP aspects in new projects.
• Be a member of multi-functional teams to realize cross-departmental objectives.
• Ensuring that Innovation projects are designed and implemented within the GMP Quality framework, including compliant, timely and properly handling of quality records such as Change Controls, Investigations and CAPAs.

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

• Master scientific degree or equivalent experience.
• 4 - 6 years’ experience in pharmaceutical or chemical industry.
• Knowledge of cGMP/Qualification compliance (21 CFR Parts 211; EU Directive 2003/94/EC and annex 11/15; ICH Q7, GAMP, Data Integrity Guidelines…)
• Experience with Equipment Qualification.
• Strong ownership and quality attitude.
• You are able to deliver on commitment timelines.
• Strong analytical thinking skills and able to work in a flexible way under time pressure.
• Ability to make risk-based decisions.
• Understands the business implications regarding quality positions and decisions.
• You work accurately and proactively across organizational boundaries as One Team.
• Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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 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.

Required Skills: Preferred Skills:

Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

The anticipated base pay range for this position is: €60,000.00 - €96,255.00

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.
• 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.

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 https://www.jnj.com/.