Empower Automation Specialist

Empower Automation Specialist

• Location: Leiden (Hybrid)

• Duration of the contract: 1 year

• Hours per week: 40 hours

Imagine your next project bridging the gap between laboratory science and cutting-edge automation in a world-class biotechnology environment.

This position within the QC Laboratories at Janssen Biologics B.V. offers an exciting opportunity for an ambitious Automation Specialist. You will act as the Subject Matter Expert for automation topics, supporting test laboratories by managing and validating Empower-based methods to ensure seamless data integration, data integrity, and strict GMP compliance.

roles and responsibilities 

You will deliver and build automated methods in Empower and provide documented evidence that systems are working as intended to support the global organization and LEAN initiatives.

This will involve:

• Lead the technical implementation of new Empower projects in collaboration with cross-functional teams. Systems range from HPLCs, UPLCs to PA800s analytical instruments.

• Implement and maintain Empower solutions and identify opportunities for paperless workflows, focusing heavily on Custom Field development (front-end and back-end).

• Create and maintain administrative, technical installation, and maintenance procedures.

• Own data integrity practices, including backup strategies and disaster recovery planning.

• Provide timely lab instrument support and troubleshooting for computerized system issues.

• Ensure software implementations meet 21 CFR Part 11 compliance requirements and GMP standards.

• Perform software validation (IQ, OQ, PQ) and deliver validated methods to laboratories to enable new testing approaches for new products.

• Extract data and graphs from test methods and effectively translate lab requirements into functional Empower methods.

how to succeed 

We are looking for a self-starter with a strong analytical mindset, a sharp eye for detail, and excellent communication skills to translate business needs into reliable technical solutions.

You will also bring:

• Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent experience.

• A minimum of 1-2 years of relevant experience in the pharmaceutical industry with GMP and automation responsibilities.

• Extensive experience with Empower in a GxP environment, specifically with Custom Field development and validation (both front-end and back-end).

• Deep understanding of laboratory processes, specifically HPLC, analytical calculations, integrations, and the use of reference materials.

• Strong grasp of GMP standards, 21 CFR Part 11, and general inspection requirements.

• Highly flexible with a willingness to travel between locations (Leiden, Sassenheim, and Schiphol) as required.

• Excellent written and verbal English communication skills.

• Hands-on experience in software development and validation; laboratory experience is a plus.

• Technical knowledge of system/server infrastructure.

• Proactive ability to work independently, take initiative, and produce protocols, reports, and procedures.

• Experience with one or more of the following systems: SoftMax Pro, SDMS, Deskman, LIMS, 32 Karat, or Comet.

• Familiarity with GAMP 5, Computer System Validation (CSV), and Lean or Six Sigma methodologies.

• Dutch language skills are desirable.

benefits 

This role offers a very competitive hourly rate. This contract will run for 1 year.

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.

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”.