Ein Unternehmen der Allgeier Experts Group

Für Experten

Job GOE-99374

Quality Management within Qualification and Validation - Hamburg

Validation Engineer to provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements Validation Policies and Procedures are addressed. Primary Tasks and Responsibilities. Perform Process Validations and Equipment Qualifications
- Performing statistical evaluations of analytical data
- Performing Microbiological tests in order to achieve test method validation
- Performing Gap Assessments
- Leading of change projects and support change management process
- Supporting Quality Projects and initiatives, including but not limited to: Cost Improvement,
System Changes, LEAN, New Software Systems, etc.
- Responsible for implementing per project plan
- Communication to stakeholder
- Developing the project plan
- Crosslink the demands of related departments in order to achieve a complete
incorporation of the new test method in the release process of finished products
- Co-ordination of all activities to ensure the project stays on track.
- Managing changes to the project
- Identifying and managing risks
- Managing the project budget
- Assisting the QA Project Manager in establishing the QA projects and initiatives.
- Supporting CAPAs, NCs and Audit Observations if required to achieve project goal/ test
method implementation.
- Supporting the QA Project manager in developing, coordinating and implementing projects
for improvement of processes and/or products.
- Analyze plant data for significant quality trends and report conclusions.
- Develop and implement reports for quality data for Norderstedt and other plants if required

Requirements (Must have):
- PM experience, daily call with US(English fluent in word/writing) also fluent German
- Knowledge in Biochemical Processes
- Knowledge in Document Management Systems
- Knowledge in Validations
- Knowledge in chemistry, biochemistry, microbiology or related subjects
- Knowledge of endotoxin testing preferred
- experience in a medical device environment
- experience with GDP, GMP
- experience in test method validation
- experience in project management
- Statistical knowledge
- Strong knowledge in lab software (LIMS) preferred
- Strong knowledge in MS office

Fulltime 40h/Woche


Michael Klinger
Telefon: +49 40 8796966 – 46
  • Branche Medizin/Healthcare
  • Ort Hamburg
  • Start 15.11.2017
  • Dauer 15.05.2018
  • Vertragsart freiberuflich
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Nein, danke.