Business System Owner Automation

Business System Owner Automation

Location: Leiden, Netherlands - Hybrid working - 3 days a week on site

Duration: 12 months 

Hours: 40 hours

Johnson & Johnson Innovative Medicine is currently looking for a contractor to support us as a Business System Owner Automation (MES and PIMS) within our Digital, Operational Excellence and Strategy (DOXS) department to strengthen our team. Do you have a background in automation and have experience with MES, and / or OSIsoft PI, we may need you.

About the Company:

Johnson & Johnson Innovative Medicine, part of Johnson & Johnson Pharmaceutical Supply Chain,is focused on the development and production of monoclonal antibodies to prevent and combat infectious diseases. At the Leiden Site, over two thousand talented and multi-skilled employees are working in a diverse environment with dynamic culture, bringing innovation and reliability to the Large Molecules pharmaceutical product portfolio of Johnson & Johnson. 

Short function description:

As the Business System Owner for automated production systems you are the link between Manufacturing automation, and Quality. You collaborate closely with both local and global stakeholders on your systems and you make sure the systems stay in qualified status by managing compliance aspects (Access Management and Review, System Audit Trail Review), ensuring maintenance and focusing on continuous improvement, maintain and update life cycle documentation (including Change Controls, SDLC, review and approval of validation documentation). You support the business by managing deviations related to your systems, as well as eventual Corrective and Preventive Actions. You coordinate with Planning and Manufacturing to identify the best windows of opportunity to update, upgrade and reboot the systems (as the Site is 24/7/365 active) and communicate to all levels of the Site (from shopfloor to Site Leadership Team). You own, maintain and update Standard Operating Procedures and Work Instructions, including the Business Continuity Plan, and improve them aiming towards leaner processes. 

roles and responsibilities

• You Keep oversight  on all activities and operation of your system. 

• You ensure systems stay in a qualified state and in case of deviations, you handle these to stay in compliance. 

• You are responsible for data management and data integrity activities on your systems. 

• You are responsible to support projects, e.g. software updates or improvements, in a compliant way with minimal impact to production processes. 

• You are responsible to review and approve relevant CSV documentation.

• You are responsible for SOPs and WIs related to your systems and their maintenance and update.

• You ensure a solid business continuity plan is available for your system.

• You communicate to the whole local organization, from shopfloor to Site Leadership Team.

• GxP and Quality mindset are highly valued in our department. 

how to succeed

Essential

• Relevant education in IT/Automation or specialized in this topic in a BSc. or MSc degree in science/biotechnology/chemistry. 

• You have at least 4 years of relevant work experience with Automation and preferably experience with PAS-X MES system

• You have experience with Quality Management Systems and preferably experience with Change Controls and Deviation process.

• You align with the high standards in GxP and EHS for Pharmaceutical companies.. 

Key Competencies

• You are enthusiastic, independent,  innovative able to deal with pressure and, fast changes

• You can collaborate at different levels in the organization.

• You have a can-do attitude and focus on pragmatic solutions.

• You have great analytical skills and find it easy to find interdependencies. 

• You are quality minded and have a supportive approach. 

• You take ownership of your work and have the ability to plan and structure

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

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. 

The pay rate for this role will depend on how you are paid.

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”.