Process Expert

Novartis; Lavamünd; Hybrid; EUR 14.000 - 26.000; Vollzeit

Zusammenfassung

Novartis is seeking a Process Expert to transform manufacturing through data, digital innovation and process excellence. You will support Austrian sites remotely while collaborating with cross-functional teams to ensure product quality and process robustness.

Responsibilities include data analysis, KPI development, and maintaining compliant GMP documentation. The role emphasizes CAPA management and change controls within a global pharmaceutical context.

Qualifikationen

• Bachelor's degree or higher in a scientific discipline (Pharmacy, Biotechnology, Chemical Engineering, Life Sciences or related).
• Fluent English required.
• Experience in GMP-regulated pharmaceutical/biotech manufacturing.
• Strong GMP, data integrity, process validation and quality systems knowledge.
• Experience managing deviations, change controls, and CAPAs.
• Proficient in process data analysis, statistics, trend analysis and RCA.
• Experience with MES/SAP/eQMS and digital manufacturing environments.

Aufgaben

• Analyze process data, identify trends, and deliver insights to improve manufacturing performance and product quality.
• Develop and maintain KPIs, dashboards, and control charts for process monitoring.
• Create and maintain compliant manufacturing documentation (Master Batch Records, SOPs).
• Support deviation investigations and CAPA implementation.
• Coordinate change controls and ensure regulatory/quality compliance.
• Prepare and support validation/revalidation and CPP documentation.
• Drive continuous improvement for robustness, compliance, and efficiency.
• Provide process expertise and cross-functional training with Manufacturing, Quality, MS&T and Digital teams.

Kenntnisse

Process data analysis

Statistical evaluation

Root cause investigation

English fluency

GMP/compliance knowledge

Deviation/change control experience

Ausbildung

Bachelor's degree in Pharmacy, Biotechnology, Chemical Engineering, Life Sciences, or related

Tools

Manufacturing Execution Systems (MES)

SAP

Electronic quality systems

Digital manufacturing environments

Jobbeschreibung

Salary Range:

74.060,00 L - 137.540,00 L

Job Description Summary

#LI-Hybrid

Location: Târgu Mureș, Romania

Relocation Support: This role is based in Târgu Mureș, Romania. Novartis is unable to offer relocation support: please only apply if accessible.

Are you passionate about transforming manufacturing through data, digital innovation, and process excellence? Join Novartis as a Process Expert and play a critical role in ensuring reliable, compliant, and efficient pharmaceutical manufacturing operations. In this highly collaborative role, you will leverage your expertise in process performance, GxP compliance, documentation, and continuous improvement to support manufacturing sites in Austria remotely while partnering closely with cross-functional teams. Your work will directly contribute to product quality, process robustness, and the delivery of medicines to patients worldwide.

Job Description

Key Responsibilities:

• Analyze process data, identify trends, and deliver insights to improve manufacturing performance and product quality.
• Develop and maintain key performance indicators, dashboards, and control charts to support process monitoring.
• Create and maintain compliant manufacturing documentation, including Master Batch Records and Standard Operating Procedures.
• Support deviation investigations, root cause analyses, and implementation of effective Corrective and Preventive Actions.
• Coordinate change control activities and ensure process updates meet regulatory and quality requirements.
• Prepare, review, and support validation, revalidation, and Continued Process Verification documentation and activities.
• Drive continuous improvement initiatives that enhance process robustness, compliance, and operational efficiency.
• Provide process expertise, training support, and cross-functional collaboration across Manufacturing, Quality, MS&T, and Digital teams.

Essential Requirements:

• Bachelor's degree in Pharmacy, Biotechnology, Chemical Engineering, Life Sciences, or a related scientific discipline.
• Fluency in English.
• Proven experience supporting pharmaceutical or biotechnology manufacturing processes within a Good Manufacturing Practice regulated environment.
• Strong knowledge of Good Manufacturing Practice requirements, data integrity principles, process validation, and quality systems.
• Experience managing deviations, change controls, and Corrective and Preventive Actions throughout the product lifecycle.
• Demonstrated expertise in process data analysis, statistical evaluation, trend identification, and root cause investigation.
• Experience working with Manufacturing Execution Systems, SAP, electronic quality systems, and digital manufacturing environments.

Desirable Requirements:

• Working knowledge of German to support manufacturing documentation, training materials, and collaboration with sites in German-speaking regions.
• Experience with Power BI or similar visualization tools and exposure to technology transfer or process validation activities.

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:
74.060,00 - 137.540,00 RON

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.