VALIDATION ENGINEER MICRO LAB

PuursIFarmaceutische industrie

Functieomschrijving

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.
Profiel
  • 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.
Organisatie- en afdelingomschrijving

 

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).

Aanbod

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.

Heb je nog vragen?
Aartje Huybrechts Select Projects +32 3 612 22 92
VALIDATION ENGINEER MICRO LAB Vacature informatie
64277
zz archive Engineering / Technics
Project sourcing
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