Validation Expert

Hiring By - Biostaffic

 BioPharma

Belgium

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
About The Role
The Validation Expert performs and manages the qualification status of validated process equipment and processes, as well as modification activities to comply with cGMP requirements, on time and in the intended quality, so that site validation program conforms to overall regulatory expectations.
Your key responsibilities:
Your responsibilities include, but are not limited to:
  • Prepare and verify process requalification protocols and reports and reports;
  • Plan and perform periodic requalification activities related to manufacturing equipment and processes: i.e. sterilisation, cleaning, depyrogenation, VHP sanitisation processes, temperature mappings, integrity tests, aseptic process simulation (medium fill) processes;
  • Ensure that all validation activities in the site are performed and in line with current Novartis and cGMP requirements, manage deviations related to process requalification, and make recommendations to remedy deviations and avoid their recurrence;
  • Maintain all activities and projects in a state of inspection readiness under its own responsibility;
  • Provide technical expertise for (and possibly facilitate) risk assessments using risk management tools. Collaborate cross-functionally to help ensure that process risks are analysed, adequately controlled and adequately documented.
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.
Role Requirements
What you’ll bring to the role:
  • Scientific or Engineering degree;
  • Minimum 2 years of experience in a manufacturing / MS&T role within the pharmaceutical / biotech industry;
  • In-depth knowledge of production processes and related process equipment;
  • Fluent in English. Good knowledge of Dutch.
Work Location: Puurs (Belgium).
You’ll receive:
We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Novartis also supports a flexible work-life integration (working remotely, flexi-time schedules, ...). Your office will be based in Puurs. Locally, we offer benefits to ensure our associate's mental and physical well-being. There is a fitness available for our associates to use and we offer a bike-leasing program. We have a mental coach on site as well.
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: https://www.novartis.com/about/strategy/people-and-culture
Division
Operations
Business Unit
Ophthalmology
Work Location
Puurs
Company/Legal Entity
ALCON BEL
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes
#ALCON

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Belgium

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 18, 2024
Company Overview
Novartis Belux
Novartis Belux

Current Openings: 0

At Novartis, our purpose is to reimagine medicine to improve and extend people’s lives. We use innovative science and technology to address some of society’s most challenging healthcare issues. We hope to deliver on our purpose by discovering and developing breakthrough treatments and find new ways to deliver them to as many people as possible. In Belgium, we are proud to be one of the leading life sciences companies. This means that we can bring our innovative medicines to patients who rely on them to treat serious diseases such as cancer, multiple sclerosis, severe psoriasis, eye conditions, respiratory illnesses and many more. Our Sandoz division contributes to society’s ability to support growing healthcare needs by providing access high-quality, affordable medicines. Our people are our greatest strength: their diversity, energy and creativity are crucial to our success. They make our business by discovering, develop and facilitate access to our medicines. About 105,000 people of 140 nationalities work at Novartis around the world, with over 2,000 in Belgium in three locations including a production site in Puurs. Welcome to our BeLux page. Please take a look at our Community Guidelines: http://www.novartis.be/linkedin-community-guidelines for details about how to use and interact with our LinkedIn page.
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