Job details

Qualification and Validation Specialist

Company details

Air Consult Engineering SA provides Integrated Engineering, Project Management and Regulatory and Technical Consulting services in the pharmaceutical, biotechnology and hospital industries: controlled and critical environments, aseptic production areas, critical areas and hospital pharmacies, ultra-pure utilities, specialized laboratories with high level of constraints: clean rooms, biological containment and radioactivity, climatic chambers, animal facilities, decontamination / disinfection systems, production equipment ...

As an independent Office, Air Consult Engineering takes full responsibility for the project cycle: from project definition, up to detailed commissioning and validation, and this both for modifications of existing facilities as for the construction of new integrated units.

Air Consult Engineering claims the crucial contribution of a transversal approach in the project process by a structured listening of the requirements of the end user in all their dimensions.

Recognized by the biggest names in the pharmaceutical industry, Air Consult Engineering currently employs more than 50 people and has been growing 20% annually since 2005.

In order to meet the demand of its customers, Air Consult Engineering wishes to recruit a Qualification / Validation Specialist (m/f).

Function

Your Challenge as a Validation & Qualification Project Engineer within Air Consult Engineering:

Within the "Trades" discipline, you define the validation plans of the processes, installations and systems as well as the qualification plans of the equipment and tools and you control their implementation.

  • You define and implement validation plans (IQ / OQ and PQ) for processes, installations and equipment;
  • You carry out impact assessments to define project validation plans;
  • You carry out risk analyzes on projects;
  • You control the qualification / validation protocols before execution;
  • You coordinate and plan validation and qualification activities;
  • You participate and / or control the implementation of qualification / validation activities;
  • You control the validation / qualification reports;
  • You set up and run validation groups for processes, installations and equipment;
  • You are the guarantor of the regulatory approach to validation throughout the project process, in particular by coaching the team internally;
  • You establish a long-term relationship of trust with customers and regulatory authorities.

As a recognized player in the trade, you actively participate in Air Consult Engineering's involvement with clients and in the business.

Profile

Your Assets: A Passion for Defining and Coordinating the Implementation of Quality Assurance Policy (Organizational Methods / Process / Audit)

  • You are an Industrial Pharmacist, Bio, Civil or Industrial Engineer
  • You have a minimum of 5 years’ experience in the industrial field with a link to production, validation and process development
  • You are trained in cross-disciplinary approaches to problem solving
  • You master the processes and technical applications of the sectors in which the company is active
  • You master the tools of process analysis and risk analysis
  • You are fluent in English and knowledge of Dutch is an asset
  • You are precise, orderly, rigorous
  • Autonomous, analytical, problem-solver and visionary, you are overflowing with initiative

Keywords: Mots-Clés : pharmacien d’Industrie, pharmaceutical, pharmacist, project engineer, Assurance Qualité quality assurance, Validation, engineering, project, GMP, biotechnologie, life sciences, biotech, ingénierie, pharmaceutique, biotechnology, chemistry, bio-medical, process, audit, QA, IQ, OQ, PQ, protocole, processus

Offer

Our offer: By your expertise contribute to the development of a constantly growing SME

  • We offer you a rewarding opportunity to help benefit customers and the internal organization of Air Consult Engineering from your expertise and experience by supporting an integrated and transversal approach from the definition of project to the final documentation required.
  • You have the means and autonomy to define and develop new skills and services and thus contribute to the growth of the company.
  • The opportunity to build your professional future in a constantly evolving SME in high-tech sectors.
  • A varied function with different projects, the challenge and the passion of an SME that applies its values of trust, respect and commitment on a daily basis.
  • A company that reinforces its value by the constant concern for training and the evolutionary prospects it offers its employees.
  • An attractive and comprehensive salary package in line with your level of responsibility.

  • Location: Gosselies

AIR CONSULT ENGINEERING Sa

Aéropole I-Tech Incubator - Rue Auguste Piccard 48
6041 Gosselies
Belgium

  • Tel: 071/25.40.30
E-mail

Interested?

For more information:
Call VANESSA SIDDU
at the number: 071/25.40.30
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