Process Expert / Process Expertess

Job ID

REQ-10036720

Posting Date

Jan 16, 2025

Location

Switzerland

Summary

A new and exciting opportunity has presented itself at CGT Stein. Join our team as a Process Expert, where you will provide front-line technical and scientific support for all process-specific issues. Your role will ensure the execution of processes on time and in compliance with cGMPs, SOPs, and applicable guidelines, while continuously improving quality and productivity efficiency.

About the Role

Why join Cell & Gene Therapy?

In the Cell & Gene Therapy network, we operate daily (including weekends) to deliver life-changing medicines rapidly to patients. Individualized CAR T therapy utilizes a patient's immune system to combat specific types of cancer. T cells are extracted and reprogrammed outside of the body to recognize and fight cancer cells and other cells expressing particular antigens.

Key Responsibilities:

• Provide front-line expert support for all process-specific issues related to production.
• Act as a Subject Matter Expert (SME) for the product and process, with potential support for logistics processes as needed.
• Coordinate the timely completion of all production operations, ensuring compliance with GMP, SSE, and 5S rules.
• Deliver real-time shop floor support, addressing technical problems and implementing corrective actions as necessary.
• Conduct real-time batch follow-up and technical review of batch records.
• Ensure all production documents are routinely updated and available for process validation and revalidation.
• Execute validations where required.
• Manage the preparation and execution of changeover activities, ensuring availability of necessary resources.
• Address deviations, complaints, OOE, OOS timely and implement effective CAPAs within agreed timelines.
• Lead the Root Cause Investigation process using appropriate tools and methodologies.

Minimum Requirements:

• Experience in a GMP manufacturing process support role is desired.
• Advanced proficiency in English is essential.
• A university degree in Science, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent job experience is preferred.
• Strong scientific and technical (automation) understanding.
• Familiarity with manufacturing execution systems (MES, SAP, etc.).
• A good understanding of production processes or the ability to quickly learn them.

We offer temporary employment of a maximum of 2 years.

Why Novartis?

Helping people with diseases and their families requires more than just innovative science—it takes a community of smart, passionate individuals like you. Our teams collaborate, support, and inspire each other to achieve breakthroughs that significantly change patients’ lives. Ready to create a brighter future together?

Apply Online

Apply online using the form below. Only applications matching the job profile will be considered.

Commitment to Diversity and Inclusion / EEO:

Novartis is dedicated to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

Novartis is committed to providing reasonable accommodation to individuals with medical conditions or disabilities. If you require accommodation during the recruitment process or would like to receive more information about the essential functions of a position, please reach out to Show e-mailm">Show e-mail and provide details about your request along with your contact information.

Join our Novartis Network:

If this role does not align with your experience or career goals but you would like to stay connected with Novartis and hear about future opportunities, join the Novartis Network here.

Company Details:

• Division: Operations
• Business Unit: Innovative Medicines
• Location: Switzerland
• Site: Stein Aargau
• Company / Legal Entity: C046 (FCRS = CH028) Novartis Pharma Stein AG
• Functional Area: Technical Operations
• Job Type: Full-time
• Employment Type: Temporary (Fixed Term)
• Shift Work: No

Novartis is committed to building an outstanding, inclusive work environment with diverse teams that reflect the patients and communities we serve.