Job description
The Process & Validation Specialist plays a critical role in ensuring the seamless design, implementation, and validation of pharmaceutical manufacturing processes. This position supports the development and optimization of batch templates, facilitates process transfers, manages change controls, and ensures compliance with quality and regulatory standards throughout the product lifecycle.
Key Responsibilities:
* Support the design and development of batch templates (batch records) in alignment with product specifications and regulatory requirements.
* Assist in the transposition and transformation of technical dossiers during process transfers (e.g., from R&D to manufacturing, or between sites).
* Provide technical support for changes to batch templates, including impact assessment, documentation updates, and validation follow-up.
* Contribute to process validation activities, including IQ/OQ/PQ, performance qualification, and validation reporting.
* Support change control management, deviation investigations, and CAPA processes related to batch records and process parameters.
* Facilitate operator training and knowledge transfer for new or modified processes.
* Collaborate with cross-functional teams (QA, Production, Engineering, R&D) to ensure smooth process implementation and compliance.
2.0 Qualifications & Requirements
Education & Experience
* Bachelor’s or Master’s degree in Engineering, Chemistry, Pharmacy, Biotechnology, or a related field.
* Minimum 4–6 years of experience in pharmaceutical or chemical manufacturing, with a focus on process validation, quality, or production.
* Proven experience in process transfer, batch record design, and validation lifecycle management.
* Demonstrated experience in change control, deviation management, and CAPA systems.
* Experience in project management and team coordination is required.
* Lean Six Sigma certification or experience is highly desirable.
* MES expertise and good knowledge of Siemens Opcenter is mandatory
Technical & Digital Skills
* Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
* Experience with document management systems (e.g., SAP, TrackWise, Veeva Vault, or similar).
* Familiarity with process simulation tools or digital tools for batch record design is a plus.
Languages
* Fluent in French (spoken and written) – essential for documentation and collaboration.
* Fluent in English (spoken and written) – required for technical communication and regulatory compliance.
* Dutch is considered a strong advantage (especially for international projects or cross-border transfers).
Regulatory & Compliance Knowledge
* Strong understanding of:
o GxP and cGMP regulations
o EU Annex 1 (2022) – Sterile Medicinal Products
o FDA 21 CFR Part 211 – Current Good Manufacturing Practice
o EMA guidelines on process validation and quality systems
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.