VALIDATION ENGINEER MICRO LAB

PuursIIndustrie pharmaceutique

Description de fonction

As a VALIDATION ENGINEER for the MICRO LAB you will have the following responsibilities:

  • Must become an expert in the following domains:
              - Aseptic Validation of  Processes/Clean Rooms & Equipment
              - Knowledge and correct interpretation of all involved Pfizer/cGMP regulation
              - Support in problem solving
  • The contractor can be owner of a Quality System
               - to identify and close system performance or compliance gaps according to cGMP/Pfizer regulation
               - to improve the efficiency of the systems
               - to make sure that the correct SOPs/WI are in place
               - to share the system knowledge with team members/involved colleagues from production, engineering, QA.
  • Responsible for the validation  activities:
              - Preparation of the URS for test equipment
              - Preparation of the validation plan and protocol
              - Coordination and follow up of the practical execution of the validation tests
              - Preparation of the final validation report
  • The consultant directs analysts if applicable, who are appointed to specific tasks for the assigned projects. She/he is responsible for the reliability of the obtained results and final validation reports.
  • He/she assures that test methods used comply with current legal and Pfizer standards.
  • Prepare a maintenance/calibration program that assures that the used equipment is well maintained, validated and calibrated at regular intervals according GMP requirements and Pfizer guidelines.
  • Assure proper training and development of personnel concerning the assigned projects to obtain a proper transfer to the routine testing process.
  • Improve productivity and avoid unnecessary costs in relation to the assigned projects and plans for timely implementation.
  • You will serve as a coordinator between the Aseptic design/ Micro lab and other departments as Product Support, engineering,  production, maintenance, the chemical lab and environmental control operations.
  • You will propose for your expert domain personnel- and equipment budgets and prepare comparative studies on equipment to be purchased.
  • You will participate in corporate and site teams and audits related to his/her expert domains.
  • He/she is responsible for the safety in his/her expert domain.
Profil
  • You have a university degree in the chemical, pharmaceutical and/or biological engineering or scientific field.
  • You have a broad experience in general with a minimum of 3 years in the industry (good junior or medior/senior).
  • Knowledge and understanding of cGMP is a must.
  • You must have good knowledgemicrobiology and aseptic validation according to cGMP standards.
  • Special training and skills:
    • Good analytical and problem solving skills.
    • Good influencing skills
    • Work efficiently with people of different backgrounds.
  • You must write and speak Dutch and English fluently.
  • You have good communication and leadership skills to lead interdepartmental project teams.
  • You have good technical writing skills.
Descriptif de l’organisation et du département

 

Select Projects is part of an international full-service Human Resources organization, Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium and Dubai, we provide support to companies who need expercienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

For one of our pharma clients in Puurs we are looking for a VALIDATION ENGINEER for the MICRO lab (M/F).

Offre

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Avez-vous des questions?
Bénédicte Joret Technical Projectsourcing Select Projects +32 3 203 50 88
VALIDATION ENGINEER MICRO LAB Informations offres d'emploi
62231
Ingénieur / Technique
Project sourcing
40
Quel est mon voyage?

Postuler chez Select Projects

Vous postulez sur notre site Web ?

  • Vous postulez chez Select Projects
  •  
  • Vous recevez généralement un message dans les 24 heures ouvrables
  •  
  • Nous faisons connaissance au cours d'un entretien (téléphonique)
  •  
  • Si le courant passe, nous formulons une proposition
  •  
  • Nous débutons une collaboration. Bienvenue chez Select Projects !
  •  
  • Votre coach vous offre un accompagnement de carrière personnel
  •  
  • De nouveaux projets et de nouvelles expériences vous permettent de rester à la pointe dans votre domaine
Complément d'information sur notre procédure de candidature