Manufacturing System Expert

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

Benefits dieser Stelle

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks parental leave

Zusammenfassung

Novartis in Romania is seeking a Manufacturing Systems Expert to drive qualification, validation, and risk management across manufacturing systems in a GxP-regulated environment. You will collaborate across validation, process engineering, quality, IT, and manufacturing to optimize systems, maintain electronic batch records, and ensure data integrity while supporting continuous improvement.

The role offers a hybrid work arrangement and opportunities to influence digital manufacturing and

Qualifikationen

• Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, or related field.
• Fluency in English.
• Proven experience supporting pharmaceutical or biotechnology manufacturing processes in a GxP-regulated environment.
• Strong knowledge of qualification, validation, data integrity, risk management, and regulatory compliance requirements.
• Hands-on experience with Manufacturing Execution Systems, electronic batch records, recipes, and manufacturing master data.
• Strong collaboration and communication skills across manufacturing, quality, information technology, and engineering teams.

Aufgaben

• Lead qualification, validation, cleaning validation, and risk management activities across manufacturing systems.
• Support commissioning, testing, and qualification of equipment, utilities, and manufacturing systems.
• Analyze process and system data to troubleshoot issues and drive continuous improvement.
• Translate manufacturing process requirements into compliant system configurations and execution workflows.
• Maintain and optimize electronic batch records, recipes, master batch records, and bill of materials structures.
• Author and maintain GxP documentation while ensuring data integrity, traceability, and audit readiness.
• Support deviations, corrective and preventive actions, change controls, and lifecycle management activities.
• Deliver training, subject matter expertise, and knowledge transfer across manufacturing and operational teams.

Kenntnisse

English fluency

GxP compliance

MES

Data integrity

Cross-functional collaboration

Ausbildung

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

Tools

MES (Manufacturing Execution Systems)

Electronic Batch Records

Master Data management

Jobbeschreibung

Salary Range:

74.060,00 L - 137.540,00 L

Job Description Summary

#LI-Hybrid

Location: Targu Mures, Romania

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

Are you passionate about transforming manufacturing through the seamless integration of process, equipment, and digital systems? As a Manufacturing Systems Expert, you will play a pivotal role in supporting compliant, efficient, and innovative manufacturing operations across a GxP-regulated environment. Working in a highly collaborative, international setting, you will connect validation, process engineering, quality, automation, and manufacturing teams to optimize systems, drive continuous improvement, and ensure the highest standards of compliance and data integrity. This is a unique opportunity to influence the future of digital manufacturing while providing expert support that enables reliable product delivery to patients worldwide.

Job Description

Key Responsibilities:

• Lead qualification, validation, cleaning validation, and risk management activities across manufacturing systems.
• Support commissioning, testing, and qualification of equipment, utilities, and manufacturing systems.
• Analyze process and system data to troubleshoot issues and drive continuous improvement.
• Translate manufacturing process requirements into compliant system configurations and execution workflows.
• Maintain and optimize electronic batch records, recipes, master batch records, and bill of materials structures.
• Author and maintain GxP documentation while ensuring data integrity, traceability, and audit readiness.
• Support deviations, corrective and preventive actions, change controls, and lifecycle management activities.
• Deliver training, subject matter expertise, and knowledge transfer across manufacturing and operational teams.

Essential Requirements:

• Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, or a related field.
• Fluency in English.
• Proven experience supporting pharmaceutical or biotechnology manufacturing processes in a GxP-regulated environment.
• Strong knowledge of qualification, validation, data integrity, risk management, and regulatory compliance requirements.
• Hands-on experience with Manufacturing Execution Systems, electronic batch records, recipes, and manufacturing master data.
• Ability to investigate deviations, perform root cause analysis, and implement effective corrective actions.
• Strong collaboration and communication skills with the ability to work across manufacturing, quality, information technology, and engineering teams.

Desirable Requirements:

• German language skills and experience supporting regulatory inspections within pharmaceutical or biotechnology manufacturing environments.

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.

Skills Desired

Data Analytics