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Puurs - België - Life sciences - Pharmacie/projectleider - Project Management & Services - Professional Bachelor

Brunel | Mechelen | Permanent, Full-time

Published on Jobat.be 7 days ago

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Job description

Function: 1. 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

2. Must become an expert in the following domains:

  • Aseptic Validation of Processes/Clean Rooms & Equipment
  • Knowledge and correct interpretation of all involved cGMP regulation
  • Support in problem solving

3. The contractor can be owner of a Quality System:

  • To identify and close system performance or compliance gaps according to cGMP 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.

4. 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.

5. He/she assures that test methods used comply with current legal and Pfizer standards.6. Prepares a maintenance/calibration program that assures that the used equipment is well maintained, validated and calibrated at regular intervals according GMP requirements and guidelines.

7. Assures proper training and development of personnel concerning the assigned projects to obtain a proper transfer to the routine testing process.

8. Improve productivity and avoid unnecessary costs in relation to the assigned projects and plans for timely implementation.

9. Serves 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.

10. The contractor proposes for his expert domain personnel- and equipment budgets and prepares comparative studies on equipment to be purchased.

11. The contractor will participate in corporate and site teams and audits related to his/her expert domains.

12. He/she is responsible for the safety in his/her expert domain.

Profile

Knowledge and understanding of cGMP is a must.Special training and skills:

  • Good analytical and problem solving skills.
  • Good influencing skills.
  • Work efficiently with people of different backgrounds.
  • The candidate must write and speak Dutch and English fluently.
  • Good communication and leadership skills to lead interdepartmental project teams.
  • Good technical writing skills.

Offer

  • An interesting salary package.
  • A dynamic and high-tech life sciences environment.

Interested?

Sissi van den Langenbergh
Mechelen

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Brunel

Blarenberglaan 3, 2800 Mechelen

Routebeschrijving
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27 days left to apply

Characteristics

  • Function type: Project leader, technical responsible
  • Sector: Service and Human Resource
  • Mechelen
  • All jobs via Brunel

Offer

  • Permanent
  • Full-time

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