Automation Specialist
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 .
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
You are a proactive self-starter who works independently, builds productive relationships across all organisational levels, and translates business needs into reliable technical solutions.
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:20-10-2026Location:Contactperson:Jan Paul Favier+31 (0)88 22 77 555
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Automation Specialist in Leiden werkgever: CLS Services
Unilever is een uitstekende werkgever die zijn medewerkers de kans biedt om te groeien binnen een dynamische en diverse werkomgeving in Rotterdam. Met een sterke focus op duurzaamheid en innovatie, stimuleert Unilever een cultuur van continue verbetering en samenwerking, waarbij medewerkers de mogelijkheid hebben om door te groeien in verschillende expertiseteams. Bovendien biedt het bedrijf aantrekkelijke arbeidsvoorwaarden, waaronder 25 vakantiedagen en 13 ATV-dagen, wat bijdraagt aan een gezonde werk-privébalans.
