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Senior Qualification Engineer Pharma


Vacancy details

General information

Reference

2022-21492  

Publication date

14/08/2022

Position description

Category

OPERATIONS - ENGINEERING/PRODUCTION

Job title

Senior Qualification Engineer Pharma

Contract

Permanent contract

Contractual hours

Full time

Job description

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

Business Industry

Life sciences

Profile

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!)

Position location

Job location

Europe, Belgium, Flanders

Location

Belgium

Candidate criteria

Minimum level of education required

6. Master Degree

Level of experience

3 to 5 years

Languages

  • English (3 : Advanced)
  • Dutch (3 : Advanced)