Operations — Engineering/production
Tous niveaux d'expérience
Temps de travail
Bruxelles, Région de Bruxelles, Belgique
The Commissioning & Qualification Engineer is accountable for:
- Commissioning A well-planned, documented and managed engineering approach to the start-up and turnover of facilities, systems and equipment to the End-User that results in a safe and functional environment that meets established design requirements and stakeholder expectations.
- Installation Qualification (IQ) The documented verification that all aspects of a facility, utility or equipment that can affect product quality adhere to approved specifications (e.g., construction, materials) and are correctly installed.
- Operational Qualification (OQ) The documented verification that all aspects of a facility, utility or equipment that can affect product quality operate as intended throughout all anticipated ranges.
- Performance Qualification (PQ) The documented verification that all aspects of a facility, utility or equipment that can affect product quality perform as intended meeting predetermined acceptance criteria.
of all manufacturing equipment (sterile & non-sterile)
The Commissioning & Qualification Engineer:
- Is responsible to maintain the qualification status of systems in support of new, transferred and existing products through definition & maintenance of contemporary methodologies & standards.
- Supports 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.
- Is responsible for review of System Qualification documents.
- Is 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
- Steers under minimal guidance specialists and contractors within own discipline and/or responsibility area
- Participates in the development of global standards/guidelines, reviews local standards/guidelines
- Prepares for internal and external inspections and acts the spokesperson and Subject Matter Expert during audits and inspections, as pertains
- Qualification Engineering topics.
- Based on expertise, makes strong recommendations on investigations, investments or projects
AKKA is an international engineering consulting and R&D services company. As an innovation accelerator for its clients, AKKA 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 22.000 experts in over 25 countries, AKKA is one of the leaders in its field. In Belgium, we have close to 1000 experts active in different technical fields.
- 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
As an AKKA consultant, you will be:
- In charge of diverse transversal and empowering projects
- Supported in your career by your AKKA 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.
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