At the Biologics manufacturing site of Johnson & Johnson Innovative Medicine in Leiden, we are expanding our active Data Integrity team. Driven by the upcoming revisions to EU GMP Annex 11 regulations, our site is taking a proactive approach rather than waiting, reinforcing our on-site capacity and long-term compliance.
As a Data Integrity Engineer, you will act as a Subject Matter Expert (SME) at the intersection of process automation and Computer System Validation (CSV), with a dedicated focus on safeguarding data integrity. This is strictly not a traditional, desk-bound Quality Assurance role that merely audits documentation. We are seeking a professional with deep technical affinity and genuine shop-floor knowledge who can act as an authoritative technical peer to system owners, automation specialists, and QA.
Your daily responsibilities are structured around two primary pillars:
Remediation of Operational Systems:
- Close identified gaps across existing manufacturing and laboratory systems to achieve full, sustainable compliance.
- Remediate findings related to user access management, audit trails, and backup & restore procedures.
- Design both pragmatic short-term control strategies and structural long-term solutions aligned with business operations and Quality & Compliance.
Integration and Qualification of New Equipment:
- Autonomously prepare and validate Data Process Flow Mappings (D/PFM) for the continuous stream of incoming manufacturing and analytical equipment.
- Facilitate and lead data risk assessments with Technical and Business System Owners, including compiling and securing timely cross-functional approvals for risk assessment reports.
Guidance and Procedural Improvements:
- Enhance the procedural framework surrounding Data Integrity topics and guide system owners to meet evolving regulatory expectations.
- Bridge the gap between abstract regulatory requirements and workable, hands-on shop-floor operations.
Functie-eisen
- Experience Level: Approximately 4 to 6 years of relevant experience within regulated manufacturing environments in pharma or life sciences (around 3 years is considered too junior for this autonomous SME role).
Technical & Shop-Floor Knowledge: Hands-on understanding of equipment and automated systems, including:
- Biomanufacturing systems: Bioreactors, filtration units, and clean utilities (WFI, clean steam).
- Analytical laboratory instruments: pH meters, osmometers, and automated cell counters (e.g., Vi-CELL). Regulatory Expertise: Strong, current knowledge of revised EU GMP Annex 11, GxP regulations, CSV methodologies, ALCOA+ principles, and guidance from FDA, EMA, and MHRA.
- English proficiency is mandatory (working language of the team and facility); Dutch language skills are an advantage.
Competenties
- Excellent communication and stakeholder-alignment skills; capable of taking initiative when information is ambiguous or when data integrity concepts are new to operational teams.
- Pragmatic & Can-Do Mentality: Decisive, persevering, and result-oriented approach to resolving operational challenges pragmatically.
- Proactivity & Initiative: Self-starter mindset capable of taking initiative and driving progress even in the presence of incomplete information or ambiguous project scopes.
Arbeidsvoorwaarden
- A contract for a year of 40 hours per week (with possibility tot extend)
- A monthly project allowance 4% of your salary
- 25 holiday days.
- 8% Holiday Pay
- A travel allowance 0.21per KM or NS BusinessCard
- A good pension scheme (flexsecurity)
- Extra allowances for a home workplace budget E750.-
- A training budget, coaching, an onboarding program, and unlimited access to the Randstad Academy with over 3,000 courses and trainings
- Networking events and knowledge sessions,
We make an CV shifting at Friday 13/11 at 1PM
Bedrijfsinformatie
This international pharmaceutical and innovative healthcare company focuses on developing and delivering high-quality medical solutions and medicines. Within a dynamic, fast-changing campus environment, diverse disciplines and quality levels collaborate closely to translate scientific innovations into impactful healthcare. The organization upholds the highest standards for safety, health, environment, and quality (EHS&S and GMP). Driven by a strong quality mindset and continuous focus on process improvement, the company ensures a reliable and safe infrastructure where both internal experts and external facility partners collaborate to deliver sustainable, efficient campus facilities.
About the client:
You will work within the Analytical Development department of a leading pharmaceutical organization. The Testing Operations team (part of Strategic Operations) fosters a collaborative, quality-focused culture centered on professional standards and continuous improvement.
About Randstad Professional:
Randstad Professional acts as your career partner and mentor. We connect ambitious bachelor's and master's graduates with top-tier players across the Life Sciences industry. In addition to securing an assignment that aligns with your goals, we provide personalized coaching, active career guidance, and access to industry-specific training via the Randstad Academy to keep your career moving forward.
Good to know: You'll receive a WhatsApp message from us within 15 minutes of applying. We'll ask you a few short questions about your application to help you more quickly. Don't have WhatsApp? No problem! We'll contact you by phone or email.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Randstad Professional. Heb jij een uniek talent? We ontmoeten je graag.