Validation Lead

**Location**:Kundl, Austria #LI-Hybrid

**About the Role**:
14 years of experience with marketed Biosimilars More than 40 years of experience in Biotech production and a growing product portfolio exploiting new future key technologies such as mRNA manufacturing. Join the Manufacturing Science and Technology team in Kundl as Validation Lead and help to improve the lives of our patients.
This role reports to Senior Validation Lead.

**Key responsibilities**:
Your responsibilities include, but are not limited to:

- Coordinate process and Cleaning Validation Project

Author and review process or cleaning validation protocols and reports
- Validation 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
- Participation in health authority inspections
- Support validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV)
- Establish local procedures and templates for respective validation documentation
- Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**Essential Requirements**:

- BSc. in Biotechnology, Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical or equivalent scientific degree
- 3-5 years of experience in pharma industry, preferable in process validation and drug substance manufacturing
- Detailed understanding of manufacturing processes and related process equipment
- Strong understanding of applied statistics, quality systems and regulatory requirements across multiple health authorities
- Specialist in reviewing and writing technical reports

**Desirable Requirements**:

- MSc degree or equivalent
- Proficiency in English and German (spoken & written)

**Why Novartis?**

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:

**You'll receive**:
**Imagine what you could do here at Novartis**

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities 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 € 54.788,30 /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.

**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

**Adjustments for Applicants with Disabilities**:
**Join our Novartis Network**:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
**Division**

Operations

**Business Unit**

CONTRACT MANUFACTURING

**Country**

Austria

**Work Location**

Kundl

**Company/Legal Entity**

NVS Pharmaceutical Manu. GmBH

**Functional Area**

Technical Operations

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No