Senior Qualification Engineer Pharma
Kennziffer der Stelle
Operations — Engineering
Master / Diplom
3 bis 5 Jahre
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.
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
- 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
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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