Exp Sci Biotherapeutics RD

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

Position summary

In this role you will be part of the ELM team within the Lab Operation pillar.

The Equipment Life Cycle & Automation Specialist is a hands‑on individual contributor responsible for managing laboratory equipment lifecycle activities, supporting laboratory data systems, and ensuring data integrity and technical specifications are met for development GxP operations. The role partners with several internal / local departments and external vendors to deliver validated, connected, and fit‑for‑purpose lab solutions.

 

Key responsibilities

- Coordinate equipment introduction and lifecycle activities including coordination of IQ/OQ/PQ, decommissioning, change control input and documentation. 

- Maintain and support laboratory data system methods and reporting in collaboration with scientists. 

- Translate data integrity (DI) and regulatory requirements into technical specifications; ensure systems comply with development GxP risk profiles and DI expectations. 

- Provide technical input; review vendor deliverables and ensure timely, complete submissions. 

- Collaborate with several departments to manage access rights, audit trails, connectivity and cybersecurity considerations for connected lab systems. 

- Troubleshoot instrument/integration issues and coordinate escalation as needed. 

- Maintain an accurate inventory and status overview of connected lab systems.

 

Required qualifications & experience

- Bachelor in Life Sciences or Computer Sciences or equivalent. 

- Minimum 4 years’ relevant industry experience in pharma/biotech (GxP environment). 

- At least 2 years’ hands‑on experience with equipment validations (IQ/OQ/PQ). 

- Strong working knowledge or demonstrated affinity with 21CFR Part 11, EU GMP Annex 11 and ALCOA+ principles. 

- Demonstrated ability to work with stakeholders to translate use cases into technical/validation requirements. 

- Excellent written and verbal skills in English (required); Dutch desirable.

Technical skills:

-  Waters Empower (chromatography data system) — Strongly preferred. 

- Affinity with (laboratory) data acquisition and processing software, use of database systems (and visual reporting considered as a plus

-  Cybersecurity awareness for lab assets and ability to coordinate with stakeholders. 

- Communication & stakeholder management — Required (effective liaison with stakeholders).

Nice to have:

- Hands‑on lab experience operating HPLC/CE/cSDS or similar analytical systems

- Experience with risk/impact assessments in development programs and participation in audits. 

- Familiarity with LIMS, BIOVIA or other lab platforms. 

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Biochemistry, Coaching, Collaboration, Conducting Experiments, Data Quality, Drug Discovery Development, Chemistry, Manufacturing, and Control (CMC), Molecular Diagnostics, Patent Applications, Pharmacogenetics, Report Writing, Research Documents, Scientific Research, Technologically Savvy, Written Expression

  

 

The anticipated base pay range for this position is:

€53 500,00 - €85 445,00

 

 

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

 

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.