Ms&t Process Validation Specialist

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.

For our sterile production site located in Belgium in Brussels (Neder-Over-Heembeek) which is currently expanding its capabilities, we are currently looking for a **Process Validation Specialist**:you will act as an expert for the validation of processes and support in QbD assessments (Quality by Design). You will also be involved other activities, related to the process (cleaning, MFT) and to the manufacturing equipment’s (qualification). The **Process Validation Specialist **reports to the Qualification & Validation Aseptic Leader.

**The Role**
- Ensure that all qualifications and validations are performed according to the regulatory and customer requirements
- Be able to support Quality by Design on the drugs to be transferred or developed on the site
- Write qualification and validation protocols/reports and other documentation related to the activities
- Based on the deduced CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters) be able to develop the appropriate validation plan
- Be an expert for the validation of aseptic process (formulation, filling, holding times)
- Participate to shutdown qualification & calibration activities
- Investigate deviations as needed and execute corrections
- Define and execute improvement projects and initiatives
- Participate in customer and authority audits
- Can be involved in other process validation activities
- Ensure that all activities are performed in time and due quality
- Minimum of 5 years of experience in the pharmaceutical industry, with 3 years in a validation role or a similar position
- Experience in Quality by Design is an asset
- Maturity in the role, Integrity, Positive energy and mind-set and excellent communication skills are desirable
- Fluency in French and English is required

**Position benefits**
- What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry - a sterile business
- Potential for personal development within an international company
- Defined career path and annual performance review and feedback process
- Contributory pension and benefits package all offered from day one of employment
- 36 days’ holiday + bank holidays

**Catalent offre des opportunités enrichissantes pour faire avancer votre carrière** Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.

Catalent s'engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d'intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.

Initiative personnelle. Rythme dynamique. Un travail significatif.

Visitez Catalent Careers pour explorer les opportunités de carrière.

Catalent est un employeur garantissant l'égalité des chances et ne fait aucune discrimination sur la base d'une caractéristique protégée par la législation locale.