Process Validation Specialist

  • Company:
    Catalent Pharma Solutions
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    8 hours ago
  • Category:
    General

Description de l’emploi

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 in QbD (Quality by Design). You will also support 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

+ Be able to perform Quality by Design on the drugs to be transferred or developed on the site

+ Based on the deduced CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters) be able to develop the appropriate validation plan

+ Ensure that all qualifications and validations are performed according to the regulatory and customer requirements

+ Be an expert for the validation of aseptic process (formulation, filling, holding times)

+ Ensure that all activities are performed in time and due quality

+ Write qualification and validation protocols/reports and other documentation related to the activities

+ Investigate deviations as needed and execute corrections

+ Define and execute improvement projects and initiatives

+ Participate in customer and authority audits

+ Participate to shutdown qualification & calibration activities

+ Can be involved in other process validation activities

The Candidate

+ Minimum of 8 years of experience in the pharmaceutical industry, experience in a sterile production environment is considered an asset

+ Minimum of 5 years experience in a validation role

+ Fluency in French and English is required

+ Experience in QbD is a must

+ Maturity in the role, Integrity, Positive energy and mind-set and excellent communication skills are desirable

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 distribution de médicaments et aidez-nous à proposer plus de 7 000 produits vitaux aux patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec les sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser les nouveaux médicaments, du développement précoce aux essais cliniques et au marché. Catalent produit plus de 70 milliards de doses par an et chacune d’entre elles sera utilisée par quelqu’un qui compte sur nous. Rejoignez-nous pour faire la différence.

Catalent. Plus de produits. De meilleurs traitements. Fournis de manière fiable. ™

Visitez www.catalent.com/careers pour explorer les opportunités de carrière.

Catalent est un employeur favorisant l’égalité des chances et l’action pour l’équité. Tous les candidats qualifiés seront considérés pour un emploi sans distinction de race, de couleur, de religion, de sexe, d’origine nationale, d’incapacité, de statut de vétéran protégé, d’orientation sexuelle ou d’identité de genre. Si vous avez besoin d’une aide raisonnable pour une partie du processus de candidature ou d’embauche en raison d’un handicap, vous pouvez soumettre votre demande en envoyant un courrier électronique confirmant votre demande d’adaptation et en indiquant le numéro du poste, le titre et l’emplacement à l’adresse DisabilityAccommodations @ catalent. com. Cette option est réservée aux personnes nécessitant une adaptation en raison d’un handicap. Les informations reçues seront traitées par un employé américain de Catalent, puis acheminées vers un recruteur local qui fournira une assistance pour assurer la prise en compte appropriée du processus de candidature ou d’embauche.

Avis aux représentants des agences et des entreprises de recherche: Catalent Pharma Solutions (Catalent) n’accepte pas les CV non sollicités d’agences et / ou de sociétés de recherche pour cette offre d’emploi. Les curriculum vitae soumis à un employé de Catalent par une agence tierce et / ou une entreprise de recherche sans accord de recherche écrit valide et signé, deviendront la propriété exclusive de Catalent. Aucun frais ne sera payé si un candidat est embauché pour ce poste à la suite d’une recommandation non sollicitée d’une agence ou d’une entreprise de recherche. Merci.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

+ You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

+ You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

+ You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

+ You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

+ You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

+ See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.





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