SKOTT GROUP

About the Company

Who are we?
SKOTT GROUP is a consulting firm specialized in supporting its clients and consultants in the field of DATA.
Founded by a team of associates sharing the same values of Excellence and Transparency, we place the human at the heart of our activities.
We offer our clients professional and quality support throughout the life cycle of their data in various fields.
Within our four specialized subsidiaries, we provide our partner consultants an adapted and evolving positioning, thus favoring the durability of the collaboration.


Our specializations
Data processing (Data, Big data): the process of transforming raw data into something of value: from data collection to Artificial Intelligence through Data Governance and Data Visualization.
Advice on the strategic use of blockchain technology: From processing to storage and securing data.
Securing data (Crypto security, Cybersecurity): A service tailored to different issues and challenges. Our areas of intervention: Servers, virtualization, Networks, security, Databases, Storage, Cloud, Industrialization, DevOps, Production and Integration
Processing and digitization of clinical data (Data Science, Biometrics): We intervene on Big Data in Health, specific trades related to the rise of metadata, and trades of biometrics and statistics.


Our values
Ethics: present the advantages but also the disadvantages of the proposed products.
Professional awareness: being available for you to analyze your needs.
Team spirit: to meet all your requirements.

For our customers, this means that they can count on maximum motivation and competence.
For our employees, joining us means career development in a caring environment and mastery of cutting-edge technologies.

Want to know more about our services?
contact@skott.group
https://www.skott.fr/contactez-nous
http://skott.fr

Listed Jobs

Company Name

SKOTT GROUP

Job Title

Ingénieur Validation de nettoyage

Job Description

**Job Title:** Cleaning Validation Engineer (Freelance/Consultant) **Role Summary:** Lead the development, implementation, and maintenance of cleaning validation programs (initial and periodic) for a pharmaceutical manufacturing client. Ensure compliance with GMP, ICH, FDA, and other relevant regulations while coordinating cross‑functional teams and external vendors. **Expectations:** - Operate autonomously with a strong “right‑first‑time” quality mindset. - Proactively propose improvements and drive corrective actions. - Communicate effectively with internal stakeholders and international service providers in English. - Deliver complete, traceable documentation on schedule and within HSE guidelines. **Key Responsibilities:** - Define and deploy the overall cleaning validation strategy and schedule. - Conduct risk assessments to select appropriate qualification and validation tests. - Draft and maintain the full validation dossier (validation plans, rationales, protocols, reports). - Ensure all deliverables meet current pharmaceutical regulatory requirements. - Organize and oversee execution of validation tests, either directly or through subcontractors. - Review test results, identify non‑conformities, assess impact, and initiate corrective actions. - Coordinate information flow between production, labs, quality experts, and external partners. - Manage documentation traceability and provide regular status reporting to project leadership. **Required Skills:** - Significant experience in pharmaceutical validation (minimum 5 years). - In‑depth knowledge of GMP, ICH Q7/Q9/Q10, FDA guidance, and related regulatory frameworks. - Strong quality‑assurance culture with focus on “Right First Time”. - Excellent technical writing skills for protocols, reports, rationales, and deviation records. - High attention to detail and rigorous documentation practices. - Ability to work independently, influence stakeholders, and lead cross‑functional teams. - Fluent technical English; French language proficiency optional. **Required Education & Certifications:** - Bachelor’s degree (or higher) in Pharmacy, Chemistry, Biology, Chemical Engineering, or a related scientific field. - Professional certification in validation, quality assurance, or GMP (e.g., Certified Validation Engineer, ASQ Certified Quality Engineer) preferred. - Ongoing training or certification in relevant regulatory standards is a plus.

Centre-val de loire, France

On site

05-02-2026