Qualification Engineer - Life Sciences (Flanders)

In order to support our growth in the Life Science sector in Flanders, we are actively looking for a Commissioning & Qualification Engineer.

JOB DESCRIPTION

As commissioning & qualification engineer, you are accountable for the implementation of an engineering planned approach to the start-up and turnover a new facility & systems. This includes the delivery of installation Qualification (IQ), operational qualification (OQ) & performance qualification (PQ).

You:

• Are responsible to maintain the qualification status of systems in support of new, transferred and existing products through definition & maintenance of contemporary methodologies & standards.
• Support the Commissioning & Qualification Engineering Department in providing documented evidence that all equipment and utilities used are qualified and remain in a state of control so that they deliver processes and products that comply to regulatory and business specifications.
• Are responsible for reviewing the System Qualification documents.
• Are responsible for writing and executing qualification protocols, tests and –reports based on user, quality, technical and functional requirements and other relevant information as delivered by the project team. If required, he/she will also assist the project team in writing these (project) documents.
• Act as Technical Owner
• Steer under minimal guidance specialists and contractors within own discipline and/or responsibility area
• Participate in the development of global standards/guidelines, reviews local standards/guidelines
• Prepare for internal and external inspections and acts the spokesperson and Subject Matter Expert during audits and inspections, as pertains
• Based on expertise, make strong recommendations on investigations, investments or projects

ABOUT US

The Akkodis Group is an international engineering consulting and R&D services company. As an innovation accelerator for its clients, Akkodis supports leading industry players in the automotive, aerospace, rail, space, defense, energy and life sciences sectors throughout the life cycle of their products with cutting edge digital technologies

With more than 55.000 experts in over 30 countries, Akkodis is one of the leaders in its field. In Belgium, we have close to 1000 experts active in different technical fields.

YOUR PROFILE

• Work experience in pharmaceutical industry, preferred
  3 + year of experience in commissioning & qualification of pharmaceutical manufacturing equipment
• University Master Degree in (Bio-)Engineering or Science
• Strong technical skills and interest (electrical and mechanical)
• Knowledge of GMP requirements, methodologies, concepts and requirements related to system validation
• Quick learner and good eye for details
• Excellent communication and coordination skills
• Ability to work under pressure, flexibility and positive attitude to challenges would be added advantage.
• Ability to take decisions
• Ability to work independently under general direction
• Fluency in written and spoken English & Dutch

OUR OFFER

As an Akkodis consultant, you will be:

• In charge of diverse transversal and empowering projects
• Supported in your career by your Akkodis Manager
• Actor of your training plan and your personal and professional development
• Member of a dynamic and collaborative community of engineers
• Benefiting from a permanent contract
• Benefiting from a competitive salary packages including several extra-legal benefits.