Support investigations of process deviations, identifying root causes and implementing appropriate 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.
Essential Requirements
University degree in a scientific or engineering field such as pharmacy, biotechnology, chemical engineering, engineering, pharmaceutical technology, or a related discipline.
Strong understanding of manufacturing processes and the ability to quickly learn complex production technologies.
Knowledge of quality standards, validation principles, and regulatory requirements within a GMP-regulated environment.
Experience working with manufacturing execution systems and enterprise resource planning systems.
Strong communication and collaboration skills, with the ability to influence stakeholders across different functions and sites.
Fluency in English is needed, basic knowledge of French language is desired.
Experience in pharmaceutical or biotechnology manufacturing, process support, process validation, or related technical operations activities is desired.
Desirable Requirements
Prior experience in biotechnology manufacturing environments, including upstream (USP) and/or downstream (DSP) processes.
Experience in Process Validation activities, including Process Qualification (PQ), Continued Process Verification (CPV), Validation Lifecycle Management, Cleaning Validation, risk assessments, protocol/report writing, statistical analysis (e.g., JMP, Minitab), and support of deviations, investigations, change controls, and CAPAs.
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role
RON 81.900,00 to RON 152.100,00
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering:
https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Commitment to Diversity and Inclusion / EEO paragraph
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Skills Desired
Change Controls, Continual Improvement Process, Data Analytics and Digital (Inactive), GDP Knowledge (Inactive), Good Manufacturing Practices (GMP), HSE Knowledge (Inactive), Manufacturing Processes, Manufacturing Production, Operational Excellence, Process and Cleaning Validation (Inactive), Process Control, Quality Control (QC), Regulatory Compliance, Resilience and Risk Management (Inactive)
