Validation Lead

vor 3 Monaten


Langkampfen T, Österreich Novartis Vollzeit

**Summary**:
Our competence center in Schaftenau for state-of-the-art cell culture technology, specializing in the development and production of innovative biologics and biosimilars. Production of thyroid hormones, growth hormones and growth inhibitors.

**About the Role**:

- Responsible and supporting validation activities at Drug Product Schaftenau, i.e. for filling & compounding processes, primary packaging activities (assembly & packaging), cleaning validation
- Support revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
- HT verifications, general verification studies
- Support establishing local procedures & templates for validation activities and contribute to improvements and optimization of concepts/strategies etc
- Providing senior expertise on complex process validation topics
- Presence and support of Health Authorities, internal and customer inspections

**Minimum Requirements**:

- Min 2-3 years of relevant experience in pharmaceutical manufacturing, tech transfer management / manufacturing science and technology / technical development / quality / validation
- University degree (MSc. or PhD) in Biology, Biochemistry, Biotechnology, Biochemical Engineering, or equivalent experience
- Solid understanding / insights into DP production (aseptic filling) and/or assembly & packaging activities and respective validation activities
- Basic experience in Project Management, good organization and planning skills
- Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines.
- Excellent relationship / external stakeholder management skills
- Ability to work in a matrix organization
- Excellent written and verbal communication/presentation skills
- Fluent in English, German desirable

**Why Novartis?**

You’ll receive:
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 60.600/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

We are open for part-time and job-sharing models and support flexible and remote working where possible.

**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

Adjustments for Applicants with Disabilities:
Join our Novartis Network:
Division

Operations

Business Unit

Innovative Medicines

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Alternative Location 1

İstanbul Kurtköy, Turkey

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No


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