Beschreibung
Role & Background:For our client in the pharmaceutical sector we are looking for a Verification Engineer. Within the department, the Section Verification Engineering is responsible for the generation and management of experimental and cGMP verification and qualification activities providing objective evidence that the medical device/combination products/packaging system perform according to patient`s and technical needs. Thereby, we support the evaluation, selection, design, development, characterization, and industrialization of medical devices, combination products and packaging systems (e.g., pre-filled syringe, needle safety device, auto-injector, injector pen, infusion pump, new & break-through & platform technology, blisters, bottles, special packaging).
Your Main Tasks & Responsibilities:
- You will organize & conduct experimental characterization and cGMP verification / qualification of medical devices/combination products/packaging systems
- You will support, evaluate, develop and validate new test methods & technologies
- You will support, coordinate and conduct test method & technology transfer to clinical / commercial sites
- You will support, evaluate and implement new, state-of-the-art lab testing equipment including qualification, CSV
- You will document (e.g., protocols, reports, risk assessments) according to cGMP requirements
- You liaise with and provide technical support to key customers in development (e.g., Device Sub-Teams, pharmaceutical development), clinical and commercial operations (e.g., filling, assembly and packaging), quality and regulatory departments, supply chain
- You will apply internal and external cGMP and normative requirements (e.g., USP, Ph. Eur., ISO, ASTM) reflected in our operational processes. This includes the following activities (among others):
- Support, lead and track change control activities for test methods and lab processes incl. impact assessment on test method validation and compliance of existing lab processes
- Support the development and completion of robust, risk-based medical devices / combination products
- Design Verification strategies and method validations
- Analyze test data (e.g., design capability, trending, k-value, reliability, DOE)
- Support, lead and track management of unexpected events (e.g., discrepancies, complaints) for these medical devices / combination products within cGMP regulated area
You have the following skills and experiences:
- Technical education, BS or advanced degree in Engineering or Science discipline (pharmaceutical/ natural/biomedical/materials/mechanical science or a related field)
- Experience in the development of medical devices / combination products / packaging systems with focus on practical testing / verification / qualification; or pharmaceutical development (e.g., formulation, analytics); preferably for parenteral drug products; and covering the specific responsibilities elaborated above
- Experience of working in pharma or other closely-regulated environment under cGxP, QSM or similar working practices
- Good knowledge of legislation, regulation, industry standards around the area of medical devices / combination products (Design Control)
- Strong motivation to conduct tests and generate data to enable sound product development. Hence demonstrable practical knowledge and experience is required in:
1. Functional/physical testing (e.g., container closure integrity, compression/tensile testing, dimensional measurements)
2. Analytical testing (e.g., spectroscopic methods)
3. Wet lab skills
4. Work with hazardous substances
4. (Jigs & fixture design)
- Good knowledge of the following:
1. Statistical techniques
2. Risk management
3. Root cause analysis
4. Change/discrepancy management (e.g., Trackwise)
- Excellent command of spoken / written English and good German skills
- Standout colleague with excellent communication skills
- Very good organizational, independent working skills
- Analytical, solution-oriented thinking
- Excellent documentation practices
Reference no: 919443KW
Role: Verification Engineer
Industry: Pharma Industry
Workload: 100%
Location: Basel
Start date: 20 July 2020
Duration: 12 mos +
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.