Staff Engineer, Quality Engineering - 2406197069W

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 https://www.jnj.com/.

Within Janssen Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Staff Quality Engineer . You will be a member of our quality engineering team, ensuring quality oversight for highly automated production equipment related to manufacturing of Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product Intermediates at the Janssen 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.

Janssen 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. Janssen Supply Chain Quality (JSCQ) 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 highly automated production equipment.

Job Description :

Your main responsibilities:

• To assure that all Computer Systems Qualification/Validation related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase).

• Review and approve Qualification/Validation 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 Computer Systems Qualification/Validation 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/Validation 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.

Job Qualifications:

• Master scientific degree or equivalent experience.

• 4 - 6 years’ experience in pharmaceutical or chemical industry.

• Knowledge of cGMP/CSV compliance (21 CFR Parts 211; EU Directive 2003/94/EC and annex 11/15; ICH Q7, GAMP, Data Integrity Guidelines…)

• Experience with Computerized System Validation /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.

Qualifications

• Master scientific degree or equivalent experience.

• 4 - 6 years’ experience in pharmaceutical or chemical industry.

• Knowledge of cGMP/CSV compliance (21 CFR Parts 211; EU Directive 2003/94/EC and annex 11/15; ICH Q7, GAMP, Data Integrity Guidelines…)

• Experience with Computerized System Validation /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.

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. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Geel

Organization Janssen Pharmaceutica N.V. (7555)

Job Function Quality Engineering

Req ID: 2406197069W