Senior Quality Engineer

Senior Quality Engineer 

Location: Leiden, Archimedesweg

Duration: 6 months

Hours: 40 hours per week, hybrid (3 days on-site)

Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-skilled people are working in a high-performing culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Compliance team in Engineering, Validation and Maintenance (EVM) department we are looking for an enthusiastic and dedicated Senior Quality Engineer.

The Engineering-Validation-Maintenance (EVM) department (> 35 persons) is a motivated and dynamic team responsible for the technical support of all utilities, production and laboratory areas and all involved equipment at the Janssen Vaccines & Prevention site in Leiden. We work in a challenging environment where we make great progress in commercializing our vaccines. Engineering has a large project portfolio to sustain/improve the existing environment. The Compliance group looks after the correct qualification and validation status of GMP critical equipment and processes. Furthermore, the compliance group is responsible for the overall quality and safety programs within EVM. The key-focus point of the maintenance groups (U&B, Automation and Equipment group) is asset maintenance management of all assets within JVP.

roles and responsibilities.

Reporting to the compliance supervisor, your main focus will be on Quality and GMP related aspects of maintenance/engineering and qualification activities, as well as Process Excellence related processes and projects.

This will involve:

• Quality and GMP related aspects of the maintenance/engineering and qualification activities, which will assure that our technical support is delivered within the compliance regulations of the Pharmaceutical and Johnson & Johnson standards and guidelines in an effective way.

• All Process Excellence related processes and projects which will further embed and improve the lean culture and analytical troubleshooting capabilities of the organization.

• Be facilitating the ongoing improvements program within EVM.

• Subject matter expert on Validation activities.

• Provide support to all sub-groups within EVM in optimizing and aligning their internal processes and communication.

• Utilize multifaceted industry and process excellence methodologies on an expert level (e.g. 6-sigma, greenbelt methodologies).

• Implement/maintain a system capable of visualizing the EVM performance and metrics Key Milestones and Actions.

• Set-up metrics and trend per sub-department.

• Be in the lead of the process to safeguard EVM’s performance within GMP boundaries.

• Provide complex team support to all sub groups within EVM on handling and follow up of CAPA’s, Events, deviations etc.

• Ensuring comprehensive measurement systems to monitor the effectiveness of quality and critical systems.

• Pro-actively seeking contact with all business partners of EVM to adjust and align the interaction.

• Conducting & following internal audits.

• Be the Quality representative of EVM.

• Support engineering, maintenance with advise on Process Excellence (PE) aspects usage in maintenance and project execution.

you will bring:

• Minimum of 4-8 years of experience as a quality engineer or within a GMP environment related to Process Excellence.

• Bachelor degree preferably in one of the following disciplines: Mechanical engineering, Electrical engineering, Installation Technics or Process Engineering.

• Experience in Process Excellence.

• Yellow & Greenbelt certified preferred.

• Good skills in communication, risk analyses, understanding GMP requirements (Annex 11), Validation and qualification aspects of pharmaceutical and/or bio processing equipment, utilities and facilities.

• Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and Validation (e.g. FDA, GMP, ICH, ASTM, ISPE, etc.).

• Experience in a maintenance or engineering organization within biotechnology/pharmaceutical/process industry environment (Preferably).

• Minimum of 4-8 years work experience in similar job as quality engineer.

• Or several years of work experience in GMP environment with relevant projects/experiences related to Process Excellence and Quality.

• Strong communicator and team player, good in building relations with variety of people and departments.

• High degree of accuracy, initiative, and independence.

• Flexible, can deal with changing priorities and stress resistant.

• Enthusiastic Team player, flexible, “Can do” attitude, critical and proactive.

• Analytical and organized.

• Quality & critical mindset.

• Open for continuous improvement and development of organization, processes and people.

details

This is a hybrid position (3 days on-site, 2 days at home). This role will be for the duration of 6 months

you are welcome here.

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process.

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

Diversity, Equity & Inclusion.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.