NC Automation Specialist

NC Automation Specialist

• Location: Leiden (Hybrid)

• Duration of the contract: 1-year (Possible extension)

• Hours per week: 40 Hours

Imagine your next project driving the automation and compliance of a cutting-edge quality control laboratory.

We are seeking an experienced Automation Specialist with a strong affinity for analysis methodology and computerized systems to support our QC laboratories. You will act as the Subject Matter Expert for automation topics — including data integrity, introduction and maintenance of computerized systems and laboratory robotics — and help ensure GMP compliance while supporting LEAN initiatives across the team and process.

roles and responsibilities

The primary responsibility of this role is to perform, document, and manage investigations regarding non-conformances, focusing on root cause identification and implementing CAPAs in accordance with GMP, particularly concerning quality records that impact automated systems.

This will involve:

• Lead technical implementation of new laboratory systems in collaboration with cross-functional teams. Systems range from standalone analytical instruments to complex global platforms interfacing with LIMS.

• Act as the vital link between Lab/Production and automation, translating operational needs into robust automated solutions.

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

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

• Provide timely support and troubleshooting for computerized system issues.

• Ensure equipment implementations meet 21 CFR Part 11 compliance requirements.

• Participate in lab systems initiatives and projects in cooperation with the global organization and aligned with business needs.

• Support and troubleshoot day-to-day challenges as part of the support team.

• Lead and conduct thorough investigations of non-conformances related to testing (raw materials, in-process materials, Drug substance, Drug product) and ancillary processes.

• Define, coordinate and/or implement appropriate correction/corrective & preventive actions and effectiveness checks associated with Non-Conformance records.

• Perform root cause analysis using appropriate tools (e.g., Operator interview, Fishbone, 5 Whys, KT analysis) and ensure comprehensive corrective and preventive actions (CAPA) are defined and implemented.

• Act as SME and participate in (the preparations of) internal audits and external Inspections, as deemed applicable.

how to succeed

We are looking for a solution-oriented self-starter who can translate business needs into reliable technical solutions, with strong documentation skills and a collaborative mindset to support global projects.

You will also bring:

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

• Strong background as a Generalist QA, with extensive experience in GMP inspections, quality records, and data integrity.

• Proven experience with Comet and SAP Change Control Management.

• Strong domain knowledge: Experience managing quality records that impact automated systems, and the ability to seamlessly bridge the gap between Lab/Production and automation.

• Solution-oriented mindset with a strong affinity for both automation and quality.

• Minimum 2 years’ experience in the pharmaceutical industry with GMP and automation responsibilities.

• Hands-on background in software development and programming.

• Experience with (Computer) System Validation in a GxP environment.

• Strong analytical thinking, technical problem solving, and planning/prioritization skills.

• Proven ability to engage and build productive relationships across all organizational levels.

• Excellent written and oral English.

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

• Laboratory experience is a plus.

• Dutch language skills are desirable.

• Experience with any of: Empower, Softmax Pro, SDMS, Deskman, LIMS, 32Karat, Trackwise systems.

• Experience with robotics or programming (in particular TECAN).

• Familiarity with GAMP5 and 21 CFR Part 11.

• Lean/Six Sigma experience.

benefits This role offers a very competitive hourly rate. This contract will run for a 1-year duration (with possible 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.

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”.