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Quality

ES CSV Engineer

  • Job Title ES CSV Engineer
  • Function Quality
  • Sub Function Validation
  • Location Leiden, South Holland, Netherlands
  • Date Posted
  • Requisition Number 2206092980W
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Description

The Execution Systems (ES) department is a dedicated team of enthusiastic and skilled Automation professionals with various technical expertise. Responsibility lies in the (support of) implementation, validation, qualification and maintenance of the ISA-95 level 1 and 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the Leiden manufacturing facility. We ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.

Computerized System Validation (CSV) (Sr.) Engineer We have an excellent opportunity for a Computerized System Validation (CSV) (Sr.) Engineer to work within the Execution Systems department to support the CSV team. In this role you are part of and strengthen the ES CSV team and report to the Team Lead. You will be based at the campus in Leiden, The Netherlands.

The responsibilities & the impact You will have:

As an enthusiastic individual contributor, you support effective teamwork, communication, collaboration and build positive partnerships. In this role you will work in a dedicated team focused on commissioning and qualification of automated Systems across all business units at our Leiden manufacturing facility. You are part of multidisciplinary project teams and will work together with other groups for the introduction of new products, systems and processes.  All phases will be executed according to cG(a)MP requirements.

The candidate should have solid understanding of both business processes and process automation, be a good communicator with accompanied collaboration and influencing skills. Besides, you are a passionate change agent, who should constantly keep pace with industry trends.

Qualifications

Who you are:

You have and academic degree (Bachelor’s / Master’s) in a technology related subject area (e.g. Engineering, Industrial Automation, Information Technology, Computer Science etc.) or commensurate hands on experience. You are intellectually curious about new technologies and are constantly learning in automation and digitalization space.

Qualifications:

  • Commissioning and Qualification experience in bioprocessing, industrial automation, information technology or meaningful engineering discipline is required.
  • Demonstrated experience working in a similar role with a required minimum of 6-8 years.
  • Experience in industrial automation technology and standards, validation and/or recipe management in pharmaceutical industry is preferred.
  • Experience in a GxP regulated environment and proven knowledge of current Good Automated Manufacturing Practices (GAMP).
  • Strong knowledge of computerized SDLC approach is required including cGMP regulations related to CSV such as GAMP5, 21 CFR Part 11 and EU GMP Annex 11.
  • Commissioning and validation coordination experience is preferred.

Key Competencies:

  • Good organizational skills, including experience organizing self and others, coordinating, and initiating work arrangements with minimal direction and the capacity to work under pressure.
  • Demonstrated high level communication skills and excellent interpersonal and relationship building skills including the ability to work independently, flexibly, and collaboratively, and to negotiate effective business outcomes. English required and Dutch preferred.
  • Ability to create a path forward even if the solution is not yet clear or there is no standard process.
  • Decisive, pragmatic, and persevering with a can-do mentality.

This is what awaits You at J&J

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals. We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. You’ll have an opportunity to work for a global market leader working in a dynamic and inspiring working environment with many opportunities to work on exciting projects and assignments. Examples of some of the benefits offered are:

  • Flexible working arrangements with J&J Flex, enabling you to work from home.
  • 36 holidays. Based on full-time employment and 20 statutory holidays + 16 non-statutory holidays.
  • Global Parenteral Leave policy offering 12 weeks of leave (birth/parenteral, adoption/foster care and parenteral) at 100% pay to parents.
  • and more

For more than 130 years, diversity, equality & 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 in The Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one feels that they belong and can reach their potential. No matter who they are. Diversity, Equality & Inclusion at Johnson & Johnson means “You Belong”!

Your next move could mean our next breakthrough.

We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.

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