Position description
Category
OPERATIONS - ENGINEERING/PRODUCTION
Job title
Qualification Engineer - Life Sciences (Flanders)
Contract
Permanent contract
Contractual hours
Full time
Job description
JOB DESCRIPTION
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 (., 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
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.
Business Industry
Life sciences
Profile
YOU 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
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.
Position location
Job location
Europe, Belgium, Brussels Region, Brussels
Location
Belgium
Candidate criteria
Level of experience
All levels of experience
Languages
English (3 : Advanced)
