Lead automation engineer Data integrity & Cyber security

Auris Health

Auris Health

Software Engineering
Leiden, Netherlands
Posted on Wednesday, September 6, 2023



This role is open to applicants who wish to work full time or part-time (min. 80% of a working week), or who are returning to the workplace after a career break.

This role is open for lead industrial automation engineers that are eager to take the challenge in maturing and driving our Data integrity and Cyber security program – automation perspective.

Live Our Credo & Pursue Our Purpose:

As part of the Johnson & Johnson family of companies, Our Purpose is ‘We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.’ We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.

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 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”.


At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease! Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

AKE Asset Management (MAM) organization:

The MAM organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems activities. This occurs in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing & Technical Organization (MTO) and in conjunction with key partners, to create one integrated internal/external network.

Job Summary:

MAM - Execution Systems (ES) is a dedicated team of enthusiastic and skilled Automation professionals with various technical expertise, responsible for 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.

The Execution Systems lead industrial automation Engineer – Data integrity & Cyber security is a specialist in the field of industrial automation with broad experience of systems across this sector in combination with leading expertise on data integrity and cyber security. The lead industrial automation engineer feels naturally comfortable with the responsibility of driving progress in maintaining and enhancing our ES systems together with the technical system owners as well as defining best practices and continuous growth in standards across systems and global platforms. With this attitude you make ensure we are delivering current production needs and will be driving future readiness in a constantly evolving environment.

You will be accountable for data integrity and cyber security gap assessment and gap remediation and strategic governance model roll out. With close collaboration with the technical system owners, you will lead the strategy and implementation plan to further mature our data integrity and cyber security maturity toward high level of integrated governance standard.

The responsibilities and the impact YOU will have:

An Execution Systems lead industrial automation engineer - Data integrity & Cyber security ensures that all GxP Data and Computerized Systems are treated according to industry and regulatory guidelines throughout their Life Cycles. Ensures departmental awareness of data integrity and cyber security as it relates to paper and electronic records and ensures good documentation practices for electronic and paper-based data are in place. Proficient in the application of 21CFR Part 11 and Annex 11 regulations as well as stays current with updates to these regulations. Offers guidance and support to the business to improve GxP processes related to data integrity topics such as Security / User Access Management, Audit Trail Review, Backup & Archival.

  • Drive change and progress in the roll out of a global governance model. Strategically stay involved to define and mature in our standards as a platform in data integrity.

  • Understands both technical and procedural requirements of Data Integrity and Cyber security in manufacturing and analytical environment.

  • Collaborates with Business System Owners, Technical System Owners, QA, and Training to identify the most efficient action to be taken for any system and at any step of the data flow.

  • Identify potential data integrity and cyber security gaps and leads activities toward remediation.

  • Improves the procedural framework related to data integrity & cyber security topics.

  • Design a train program for the department to ensure awareness and compliance with data integrity and cyber security

  • Guides Business System Owners and Technical System Owners in meeting current and prepare for future expectation of data integrity and cyber security.

  • Project management capabilities.

  • Craft, lead technical strategic plans.


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

Capabilities identified as priority for our Workforce of the Future are:

  • Digital & Technology
  • Change Leadership
  • Critical Thinking & Problem Solving
  • Process knowledge & expertise
  • End to End mindset


  • A technical education / degree in industrial automation or relevant engineering discipline is required, at Bachelor level or higher

  • Experience in a GxP regulated environment with a required minimum of 4-6 years and proven knowledge of current Good Automated Manufacturing Practices (GAMP)

  • depth, up-to-date knowledge of computerized systems, GMP and specifically Data Integrity practices and recent developments in this expertise area

  • Experience in industrial automation technology standards and validation in Pharma industry

  • Proven knowledge in at least one of the following platforms, DeltaV (DCS) or SCADA.

  • Preferred knowledge in Siemens S7 & Tia Portal (PLC), Priva TC or Honeywell (Building Automation), OsiSoft (PIMS), SynTQ (Process Analytical Technology) and GxP infrastructure

Key competencies

  • Proven leadership capabilities to drive change for a department.

  • Good organizational skills, including experience organizing self, coordinating, and initiating work arrangements with minimal direction and the capacity to work under stress.

  • Demonstrated good level communication skills and excellent interpersonal and relationship building skills in all layers of the organization including the ability to work independently, flexibly, and collaboratively, and to negotiate effective business outcomes.

  • Good stakeholder communication and multi departmental alignment to ensure that Processes and Data generated by Computerized Systems at JBV meet the current requirements of data integrity and cyber security throughout the Data and System life cycles.

  • Decisive, pragmatic and persevering with a can-do mentality.

  • Process Automation insights, and always looking for the organizational process behind events.

  • Ability to understand relationships and different interests in a sophisticated organization.

  • Ability to create a path forward even if the solution is not yet clear or there is no standard process.

This is what awaits YOU at J&J:

  • An opportunity to be part of a global market leader.

  • A dynamic and inspiring working environment.

  • Career opportunities and continuous personal and professional development in areas of technology and leadership.

  • Personal Development Plan – such as access to further education & training, mentoring and coaching, development opportunities on-the-job or through exciting projects.

  • Be part of a strong global network of talent and expertise, with opportunities to learn or move to different cultures and work environments.

  • Many employee benefits like

    • 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