Senior Qualification Engineer Pharma

Festanstellung

Belgium

24/03/2023

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Kennziffer der Stelle

2022-21492

Funktionsbereich

Operations — Engineering

Branche

Life sciences

Mindestanforderungen Ausbildungsniveau

Master / Diplom

Mindestanforderungen Erfahrungsniveau

3 bis 5 Jahre

Arbeitszeit

Vollzeit

Sprachen

Holländisch
englisch

Standort

Flanders, Belgien

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Stellenbeschreibung

Within AKKA Technologies we are looking for a senior commissioning and qualification engineer to join our team on a highly important mission.


Who are we? With almost 1.000 employees in Belgium we are the biggest consultancy company focusing on innovation within engineering-projects in the industry. With our countless trainings we prepare you to being a true expert in your domain and we guide you through all projects.


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)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

Tasks & responsibilities details:

  • Execute daily validation & qualifications, writing documents (URS, IA,…) -first time right - and test execution
  • Propose improvements (Kaizen)
  • Create and follow up discrepancies
  • Research background data/qualification history
  • Internal improvement projects
  • Write QSR
  • Write/Keep up to date area Validation Master Plan
  • Coach/onboarding/training of colleagues
  • Communicate with involved departments
  • Periodic assessments (PSQR)
  • Write departmental procedures, Wis and standard test forms
  • Enter assessments and completed tasks in Trackwise
  • Initiate and follow up QI's and corrections in Trackwise
  • Reviewing and approving documents (URS, IA,…)
  • Create, own and assign KANBAN cards
  • Prepare internal/external audits
  • Write C&Q SOPs
  • Provide business support as technical owner

Qualifications

  • Work experience in pharmaceutical industry, preferred
    3 + year of experience in commissioning & qualification of pharmaceutical manufacturing equipment
  • Technical Skills, Knowledge and Qualifications: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

Profil

Our offer

You can work both as a freelancer or with permanent contract. What's in there for you when choosing a permanent contract:

  • A company car and fuel card, a good salary (based on years of experience) with a lot of extra-legal benefits.
  • Get a chance to boost your career by participating on different long term projects at big industrial partners.
  • There will be a AKKA Manager and HR Business Partner helping you through your career path. A detailed career road map is designed to help you see the next steps in your career.
  • Receive a lot of trainings or even given the opportunity to give trainings yourself (getting payed for it!)
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