Nalys

1 Job

196 Employees

About the Company

Technology management firm, with something more.
We advise on and implement strategic technology solutions for our customers in various industries.

Thanks to our strong corporate values and adhocracy management, we bring the highest value to our engineers as well as our customers through winning practices. We gather great minds to help our customers develop the innovations of tomorrow. And we love doing it.

Whether you're an engineer seeking new challenges, a customer looking for a long-term partner or an enthusiast expert, discover how we can give a sense to your passion on nalys-group.com

Listed Jobs

Company Name: Nalys
Job Title: Manufacturing Project Engineer (Clean Rooms)
Job Description: **Job Title:** Manufacturing Project Engineer (Clean Rooms) **Role Summary:** Lead and execute manufacturing and cleanroom engineering projects for a pharmaceutical partner, ensuring GMP compliance and successful qualification of equipment and processes. **Expectations:** Deliver projects on schedule and within scope, maintain thorough documentation, and collaborate across functions to achieve validation and regulatory standards. **Key Responsibilities:** - Lead studies, coordination, and monitoring of equipment and cleanroom projects. - Draft and manage User Requirement Specifications (URS) and change controls. - Participate in FAT/SAT, DQ, IQ, OQ, commissioning, and PQ activities. - Review validation protocols and Validation Package Execution (VPE) reports for equipment and systems. - Build and maintain technical documentation, project plans, and schedules. - Support training of personnel post-implementation. - Report progress and improvement opportunities to the Engineering Manager. - Assist maintenance teams with equipment support and procedure development. - Organize internal and external project execution and procurement processes. **Required Skills:** - Electromechanical engineering knowledge or equivalent experience. - Minimum 5 years in pharmaceutical project engineering. - Fluency in French and English. - Proficiency with MS Office and AutoCAD. - Strong understanding of EU GMP and 21 CFR regulations. - Ability to work independently under pressure and collaborate in cross‑functional teams. **Required Education & Certifications:** - Bachelor’s degree (or higher) in Electrical, Mechanical, or Electromechanical Engineering, or equivalent practical experience. - Demonstrated knowledge of GMP and regulatory compliance; no specific certification required.