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Vacancy

Commissioning and Qualification Engineer - Pharma

Commissioning and Qualification Engineer - Pharma

Commissioning and Qualification Engineer - Pharma

We’d love to hear from you.

Apply now

| VOS CHALLENGES ?

As a Commissioning and Qualification Engineer, your main missions will be :

  • Perform C&Q in accordance with GFD procedures, best practices, specifications and project planning documents
  • Support C&Q
  • Stay current on training of GFD procedures and Best Practices
  • Develop Commissioning and Qualification Master Plan (CQMP) and system-specific plans, if required
  • Develop System Level Impact Assessment document
  • Develop component classification documents
  • Develop User Requirement documents if required
  • Review equipment specifications to ensure FAT, SAT and PIM requirements are included, as appropriate
  • Facilitate and document Design Reviews and Design Qualifications
  • Support FAT and SAT activities
  • Perform receipt verification for components and equipment delivered to site.
  • Develop and execute commissioning documentation (e.g., installation verification, start-up, loop checks, initial calibration, functional testing)
  • Develop and execute IQ and OQ documentation
  • Collaborate with Automation contractors in support of integrated C&Q/CSV approach
  • Provide monthly status and budget updates to C&Q Lead using C&Q monthly report template

| QU’ATTENDONS-NOUS DE VOUS ?

Role Requirements :

  • BS Engineering (or equivalent experience)
  • 5 years working in pharmaceutical environment and if possible, in sterile process.
  • 10 years C&Q experience
  • Demonstrated leadership and people management skills.
  • Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
  • Good written and verbal communication skills with both technical and non-technical staff (French+English)

| QUE POUVEZ-VOUS ATTENDRE DE TMC ?

TMC est une société de conseil en science et ingénierie qui apporte une expertise technique à ses clients afin de les accompagner dans la réalisation de leurs projets et de leurs challenges. Société à dimension internationale, TMC opère donc en tant que centre d’expertise à la disposition de ses clients, ce qui nous permet de les aider à être plus compétitifs dans un monde technologique de plus en plus global et en constante évolution.

Chez TMC nous savons que ce sont les personnes qui sont moteurs de l’innovation. C’est la raison pour laquelle nous offrons les meilleures conditions possibles pour le développement de chacun de nos employés. Vous trouverez chez TMC un environnement de travail challengeant et stimulant dans lequel vous serez aux commandes de votre propre carrière.

En tant qu'employeneur, vous faites partie de notre famille TMC où l'engagement et prendre plaisir à travailler sont des éléments essentiels de notre culture.

| POURQUOI CHOISIR L’EMPLOYENEURSHIP?

Notre modèle de l’Employeneurship est unique, c’est une véritable innovation dans le secteur du conseil en haute technologie. C’est LA relation de travail du 21ème siècle pour les professionnels techniques hautement qualifiés. Il est construit autour de 5 piliers principaux:

Vous aurez un contrat de travail à durée indéterminée vous offrant stabilité et sécurité,

Vous apprendrez à connaître votre valeur sur le marché et aurez une part des bénéfices générés par votre travail grâce à la participation individuelle aux bénéfices,

Nous vous accompagnerons grâce à un coaching personnalisé et un plan de formation conçus pour vous aider à développer vos compétences entrepreneuriales,

Notre structure en cellules de compétence technique vous fournira un réseau d’experts fort, significatif et pertinent,

Le Lab’ entrepreneurial vous offrira un terrain de jeu pour explorer de nouvelles idées et peut-être participer au lancement de start-ups

Is TMC a perfect fit for you? We’d love to hear from you.

Feel Free to Contact

Julien Baraya

Business Manager, France

Tel: 0763641761

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Our knowledge is as broad as our customer base is varied. From big international pharmaceutical companies to biological start-ups taking their first steps, we help all our customers to fulfill their ambitions quicker than they would have imagined possible. We help our clients within R&D, with product development, process development and optimisation, and of course with our razor-sharp consultancy and our crystal-clear style of (content) management.
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