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Enterprise Architect @Bilthoven Biologicals

Bilthoven

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Bedrijfsprofiel – Company profile

About Bilthoven Biologicals
Bilthoven Biologicals (BBio) is an international biopharmaceutical manufacturing company. With approximately 500 colleagues, BBio works together on the production of vaccines, such as polio, diphtheria-tetanus-polio (DTP), and BCG. BBio supplies vaccines to organizations including the World Health Organization (WHO) and UNICEF, thereby contributing to the global program to eradicate polio. BBio is part of the Poonawalla Group, owner of the Serum Institute of India, the world's largest vaccine manufacturer. In addition, BBio is investing in the modernization and expansion of their production capacity.

About the Information Management Department
The Information Management department is responsible for information provision, systems, and infrastructure. We work according to a GxP and GAMP 5 validated approach. Part of the IT is outsourced; governance and collaboration with external partners are an important part of your role.

Most importantly: BBio is a growing company. This offers opportunities for people with passion and ambition. Don’t expect a bed of roses, but do expect the chance to grow with BBio.

Samenvatting – Summary

As an Enterprise Architect, you will be responsible for designing, monitoring, and developing BBio’s enterprise, information, and application architecture within a GxP and GAMP 5 environment.

Omschrijving – Description

Your Role
As an Enterprise Architect, you will be responsible for designing, monitoring, and developing BBio’s enterprise, information, and application architecture within a GxP and GAMP 5 environment. You will operate at the intersection of strategy and execution: developing organization-wide frameworks and ensuring they are effectively applied in projects.
You will actively contribute to the modernization of the production and laboratory processes and ensure coherence, quality, information security, and compliance in a complex IT landscape including ERP (SAP), MES, and LIMS.
 
What Will You Do?
Architecture & Governance
  • Develop and maintain enterprise, information, and application architecture.
  • Establish and monitor architecture principles, standards, and guidelines.
  • Guide strategic implementations such as SAP upgrades, MES, and LIMS systems.
  • Ensure compliance with regulations (GxP, GAMP 5), information security, and data integrity.
 
Digital Roadmap & Strategy
  • Develop and monitor the digital roadmap in line with organizational goals.
  • Translate business needs into target architectures and concrete solution directions.
 
Project Contribution
  • Actively involved from design to realization.
  • Collaborate with internal teams and external suppliers with a focus on security-by-design, validation, and lifecycle management.
 
Coaching & Quality Assurance
  • Guide teams in applying architecture principles, security, and GAMP 5.
  • Act as a sparring partner for project leaders, product owners, and specialists.
 
Collaboration & Communication
  • Intensive coordination with business, IT, QA, QC, Information Security, and partners.
  • Clear communication about choices, risks, and dependencies.
 
Who Are You?
You are a strong architect who provides direction and rolls up your sleeves. You can make complex subjects understandable and connect stakeholders in an environment where quality and compliance are crucial.
 
Knowledge and experience
  • At least 5 years of experience in an (enterprise) architecture role.
  • Experience with enterprise, information, and application architecture.
  • The right understanding of information security (e.g., ISO 27001/27002, NIS2), security-     
     by-design, and risk management.
  • Experience in GxP environments and with GAMP 5 (CSV/CSA, risk-based validation,
     data integrity/ALCOA+)
  • Preferably knowledge of SAP, MES, LIMS, and production/laboratory systems.
  • Experience working in projects and with Agile methodologies.
  • A higher professional education (HBO) or university degree and good command of
    English.
 
You are:
  • A substantive leader who provides direction.
  • Strong in communication and persuasive.
  • Curious, flexible, and eager to learn.
  • Hands-on: involved from design to realization.

Aanbod – Offer

Bilthoven Biologicals offers
  • Salary: €4,145 – €8,019 gross per month (40 hours), scale 10 or 11 according to the
     collective labor agreement (CAO).
  • Employment: 32–40 hours per week.
  • Extras: 13th month, pension scheme, and travel expense reimbursement according to
     the CAO.
  • A role with a lot of responsibility, strategic impact, and operational involvement.
  • Work in an innovative, internationally operating organization with social significance.