Automation Specialist

CLS Services; Leiden; On-site; EUR 55,000 - 75,000; Full time

Job summary

Janssen Biologics in Leiden, Netherlands, seeks an Automation Specialist to serve as SME for automation in QC laboratories. The role covers data integrity, computerised systems, and robotics.

You will lead investigations of non-conformances across raw materials to drug product, perform root cause analyses, and coordinate CAPA actions. The position requires a HBO/BSc in Life Sciences or related field, 2+ years in GMP automation, and experience with systems like Empower, LIMS, Trackwise, and TECAN

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, or equivalent.
• 2+ years in pharma GMP/automation role or similar.
• Solid knowledge of GMP regulations and FDA/EMA guidelines.

Responsibilities

• Lead investigations of non-conformances in testing of materials and products.
• Conduct root-cause analyses and coordinate CAPA actions.
• Oversee automation projects from standalone instruments to global platforms interfacing with LIMS.
• Ensure data integrity and compliance with 21 CFR Part 11 during audits.

Skills

GMP Compliance

Non-Conformance

Computer System Validation

Data Integrity

Education

Bachelor's degree in Life Sciences or Computer Science

Tools

Empower

LIMS

Trackwise

TECAN robotics

Job description

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