Description

Building innovative MedTech or Life Science products is hard enough without getting stuck on compliance documentation. As a CSV Engineer at Janssen (Johnson & Johnson), I know exactly how to bridge the gap between technical innovation and strict regulations like GMP and GAMP 5.

How I can help:

I help startups and scale-ups get their documentation audit-ready without the need for a full-time QA department. My approach is practical and task-oriented. I specialize in reviewing and optimizing:

Validation Protocols & Reports (CSV)

Standard Operating Procedures (SOPs)

Risk Assessments & Gap Analyses

CAPA and Deviation Management

Why work with me:

What sets me apart is my ability to translate complex "Big Pharma" quality standards into workable solutions for smaller, agile teams. I don't just point out what’s wrong; I provide the technical writing and review needed to fix it.

Availability:

I am available for micro-consulting and document reviews for up to 8 hours per week. This is the ideal solution for companies that need high-level expertise on a flexible, asynchronous basis. Let’s get your project compliant and moving forward.

Languages

Dutch
Native or bilingual
English
Fluent
German
Basic

Workplace preferences

Can work on-site

Utrecht (up to 50km)

Janssen Biologics BV
CSV Engineer
January 2022 - Today (4 years and 5 months)
As a CSV (Computer System Validation) Engineer, my primary focus lies in ensuring the compliance and reliability of computerized systems within the regulated pharmaceutical industry. My objective is to utilize my expertise in CSV to develop and implement robust validation strategies that meet regulatory requirements and ensure the integrity of critical data and processes. Approach & Achievements: In my role as a CSV Engineer, I have adopted a systematic approach towards validation, beginning with comprehensive risk assessments to identify critical systems and potential areas of concern. I have designed and executed validation protocols for various software systems. Results & Added Value: Minimization of validation errors and deviations, resulting in improved data integrity and reliability. Keywords: Computer System Validation (CSV), Regulatory Compliance, Risk Assessment, Validation Protocols
Computer System Validation (CSV) Risk Assessment Audit Root Cause Analysis Data Integrity
JANSSEN PHARMACEUTICA NV
Supplier Quality Associate
January 2020 - December 2021 (1 year and 11 months)
Surveillance on the quality and compliance status for all suppliers sourcing APIs, API materials or DP materials such as excipients, raw or packaging materials, to the Janssen Supply Chain for themanufacture of Intermediates, APIs, or drug products respectively. Approach & Achievements
• • Managed changes related to supplier and/or external manufacturers.
• • Assessed deviations, corrective andpreventative actions (CAPAs), concerning suppliers and external manufacturers.
• • Established and reviewed Quality Agreements and Specifications Agreements. Results & Added value
• • Ensured assessment and qualification of suppliers and external manufacturers for new product introductions, and establishment of initial Qualification Statements. Keywords Product & Services (SAP) , Standards & Methods (GMP) , Technologies, Software & Tools (ComplianceWire, eICD, TrackWise)
ALTRAN
Innovation Consultant
September 2019 - December 2019 (3 months)
As a Innovation Consultant I am defining the Customer Insight Led Innovation Strategy. Approach
• • Visualized the collaborative tools such as Empathy Map, Customer Journey, Trend Radar and Persona Canvas that can be used to gain deeper insight into customers.
• • Incorporated the tools into a Customer Insight Led Innovation strategy consisting of three stages: Customer Value, Change, Action. Results & Added value
• • The presentation that is developed is being used by the Innovation & Design team to explain the strategy to new clients. Keywords Product & Services (Customer Requirements, Innovation Management), Specialties (Customer Journey), Technologies, Software & Tools (Customer Journey Mapping, Design Strategy) , Soft Skills (Innovation)