Vacancy number: A-2-2600071
Johnson & Johnson Innovative Medicine - Leiden (Nederland)
For our client, Johnson & Johnson Innovative Medicine, we are looking for an Automation Specialist.
Johnson & Johnson Innovative Medicine - Leiden (Nederland)
For our client, Johnson & Johnson Innovative Medicine, we are looking for an Automation Specialist.
Keywords
- Automation Specialist
- GMP Compliance
- Non-Conformance
- Computerized System Validation
- QC Laboratory
Profile
As NC Automation Specialist, you act as Subject Matter Expert for automation topics within the QC laboratories. This includes data integrity, the introduction and maintenance of computerised systems, and laboratory robotics. You ensure GMP compliance and support LEAN initiatives across the team.A key part of your role is leading and conducting thorough investigations of non-conformances related to testing of raw materials, in-process materials, drug substance, and drug product. You perform root cause analyses using tools such as Fishbone, 5 Whys, and KT analysis, and you define and coordinate appropriate corrections, corrective actions, and preventive measures (CAPA).
On the automation side, you lead the technical implementation of new laboratory systems — ranging from standalone analytical instruments to complex global platforms interfacing with LIMS — and maintain administrator, technical installation, and maintenance procedures. You own data integrity practices including backup and disaster recovery planning, and ensure implementations meet 21 CFR Part 11 requirements. You also act as SME during internal audits and external inspections.
Who we're looking for
You hold a Bachelor's degree (HBO) in Life Sciences, Computer Science, or have equivalent experience, combined with at least two years in the pharmaceutical industry in a GMP and automation-related role. You have a solid understanding of GMP regulations, FDA and EMA guidelines, and hands-on experience with software development, programming, and Computer System Validation in a GxP environment.- Strong analytical thinking, technical problem-solving, and planning skills
- Excellent written and oral English; Dutch is desirable
- Experience with systems such as Empower, LIMS, Trackwise, or TECAN robotics is a plus
- Familiarity with GAMP5, 21 CFR Part 11, and Lean/Six Sigma is advantageous
Department
You will be embedded in the QC laboratory environment, working as part of a support team and collaborating with cross-functional and global stakeholders on systems initiatives, quality investigations, and compliance projects.Company profile
Janssen Biologics develops, acquires, and markets innovative biopharmaceutical therapies, with a focus on cardiovascular disease, immunological disorders, and oncology. The organisation is committed to advancing both new and existing products through targeted research, strategic partnerships, and a strong emphasis on quality. |
Additional vacancy information
| Reference | : | A-2-2600071 |
| Contract | : | Temporary contract |
| Education | : | BSc. |
| Arbeidsvoorwaarden | : | Project for 1 year. |
| Publication date | : | 20-10-2026 |
| Location | : | View location with Google Maps |
| Contactperson | : | Jan Paul Favier |
| +31 (0)88 22 77 555 |
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