About this role
About the Role As a Process Validation Expert, you will provide technical and scientific expertise to support process validation activities across the product lifecycle, ensuring manufacturing processes remain robust, compliant, and inspection-ready. You will work with cross-functional teams across sites, including the NVS site in Huningue, to drive alignment and implement best practices in process validation. What You'll Do
- Serve as Subject Matter Expert for assigned products, manufacturing processes, and process validation activities, ensuring reliable and compliant execution.
- Provide technical support to enable smooth process execution and maintain manufacturing continuity.
- Partner with cross-functional teams, including the NVS site in Huningue, to drive alignment and effective knowledge sharing.
- Support investigations of process deviations, root causes, and implementing corrective and preventive actions.
- Oversee process changes through formal change control, ensuring full regulatory compliance.
- Lead and support process validation lifecycle activities, including process qualification, continued process verification, and validation strategy development.
- Support internal and external inspections, ensuring strong readiness and adherence to regulatory expectations.
- Evaluate process performance trends and drive continuous improvement, innovation, and product quality enhancements. What We're Looking For
- University degree in a scientific or engineering field (e.g., pharmacy, biotechnology, chemical engineering, engineering, pharmaceutical technology) or related discipline.
- Minimum two years of experience in pharmaceutical or biotechnology manufacturing, process support, process validation, or related technical operations activities.
- Strong understanding of manufacturing processes and ability to quickly learn complex production technologies.
- Knowledge of quality standards, validation principles, and regulatory requirements in GMP environments.
- Experience with manufacturing execution systems (MES) and enterprise resource planning (ERP) systems.
- Strong communication and collaboration skills, with the ability to influence stakeholders across functions and sites.
- Fluent English; basic knowledge of French is a plus. Nice to Have
- Prior experience in biotechnology manufacturing environments (upstream and/or downstream).
- Experience in Process Validation activities (PQ, CPV, Validation Lifecycle Management, Cleaning Validation), risk assessments, protocol/report writing, statistical analysis (JMP, Minitab), and CAPAs. Compensation & Benefits
- Expected Annual Base Salary Range: 81,900 to 152,100 RON (salary currency shown as USD for platform purposes).
- In addition to base salary, eligibility for performance-based bonus based on certain parameters.
- Flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
- Insurance and retirement plans, wellbeing resources, global recognition programs.
- Commitment to diversity and inclusive culture; total rewards subject to local legal requirements.