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pi is a global integrator of excellence to some of the world’s leading life science companies. From our origins as a trusted supplier of regulatory and technical support, we’ve grown to become their strategic partner of choice. We’ve grown to be bigger by learning how to be better.

pi is a global integrator of excellence to some of the world’s leading life science companies.

Senior Qualification Engineer Production

Vaktechnisch - expert
Bio ingenieur (ir.)
Burgerlijk ingenieur (ir.)
Industrieel ingenieur (ing.)
Consultancy op projectbasis
Onbepaalde duur
Voltijds
Nederlands
Engels
Antwerpen
Limburg
Oost-Vlaanderen
Vlaams-Brabant
2 jaar
Chemie en farmaceutische industrie
Elektronica en technologische industrie

Functieomschrijving

We are currently looking to expand our team with a Senior Qualification engineer production.

 

More specifically, a hands-on expert familiar with a broad range of analytical methodologies and great attention to detail. Your ability to work independently and your strong communication skills make sure you meet every deadline with a focus on total client satisfaction. 

 

 

 

Responsibilities

 

 

 

Reporting to the project leader and working in close collaboration with a team of Qualification and Validation experts, you will have the following responsibilities:

  • Create user requirements (URS) 
  • Define the validation strategy based upon the clients’ guidance and benchmarks 
  • Build validation and qualification plans 
  • Coordinate and perform FAT/SAT as well as equipment commissioning 
  • Execute tests (IQ/OQ/PQ/DQ) 
  • Coordinate and review the related GMP documentation needed for change control 
  • Ensure the planning of validation and qualification strategies in accordance with all the concerned parties (production/QA/maintenance) 
  • Ensure the operational management of the technicians dedicated to the validation 
  • Maintain equipment to support GMP manufacturing 
  • Foster innovation and continuous improvement on process, and on qualification and validation projects 

 

Algemene vereisten

Your profile:

  • You hold at least a master’s degree in engineering, bioengineering, biology, pharmacy or related fields.
  • You hold at least five year of experience in qualification / validation in GMP environment (production). 
  • You are familiar with the processes and legal requirements for pharmaceutical industry. 
  • You have technical understanding of manufacturing equipment (autoclaves, washing machines, packaging, tanks,...) and processes specific to Pharmaceutical manufacturing preferred. 
  • You are familiar with creation and verification of qualification equipment plans (FAT/SAT/DQ/IQ/OQ/PQ). 
  • You are proactive, have good communication skills, and can work in a multidisciplinary team towards a common goal. 
  • You are proficient in Dutch and English.

Aanbod en voordelen

It is essential that each new team member fits our corporate culture. We believe in an open and collaborative workplace where transparency is paramount. We encourage creativity, challenge accepted best practices and focus on internal knowledge. But most of all, we hold integrity and honesty in high regard. To us, mutual respect is the key to long-term growth. We focus on total client satisfaction in everything we do.

 

Our offer includes a highly competitive remuneration program, including multiple supplementary benefits. You will have the chance to shape your own career and to further grow your professional expertise. Become part of an ambitious team of experts with a focus on people, quality and knowledge.

 

Interested? Apply today and we will be in touch soon.

Sollicitatieprocedure

Please send your resume to nhoste@3-14.com and we will get in touch!