Senior Quality Engineer

Senior Quality Engineer 

Location: Leiden (hybrid working)

Duration: 12 months

Hours: 40

Imagine your next project providing key leadership in continuous improvement for a dynamic engineering and validation team working to commercialize life-saving vaccines at a world-class site.

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

As a senior quality engineer, you'll be the key person to provide leadership and support on the continuous improvements of both internal and external business processes, reporting to the compliance supervisor. 

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

how to succeed

You will need a minimum of 4-8 years of relevant experience in a GMP environment and a strong analytical, communicative, and proactive mindset. You will also bring:

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

• Specific Knowledge:

• Experience in Process Excellence preferred.

• 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.)

• Preferably:

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

• Experience:

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

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

• Competences:

  • 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 continued improvement and development of organization, processes and people.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 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 Janssen

Janssen is the Pharmaceutical Companies of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

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.

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”.