Verification Engineer (m/f/d)

Verification Engineer (m/f/d) – cGMP / parenteral drug products / medical devices / combination products / jigs & fixture design / Functional / physical testing / English & German (B1)

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Verification Engineer (m/f/d).

Background:
Pharma Technical Development Europe Biologics brings game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development. Our daily work also includes compiling of regulatory documents and the transfer of development projects to commercial manufacturing. We are striving for a caring and sensing network organization which lives a culture of trust and collaboration. Our smart people drive innovation through their expertise, passion and „getting it done“ mentality. The benefit for the patient is in the center of our thoughts and efforts. The Device & Packaging Development Department within Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. 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).

The perfect candidate: has a technical education, bachelor or advanced degree in Engineering or Science discipline and min. 2-5 years of experience in practical testing and characterization of medical devices/combination products, primary packaging of pharmaceutical development. Experience of working in pharma or other closely-regulated environments under cGMP is required. The candidate needs to be fluent in English and preferably in German as well (or min. B1).

Tasks & Responsibilities:
* Organize & conduct experimental characterization and verification of medical devices / combination products
* Evaluation, practical development and validation of new test methods & technologies
* Evaluation, implementation and management of testing equipment
* Documentation (plans, protocols, reports) according to cGMP requirements
* Collaborate 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 and supply chain
* Support technology transfer of medical devices / combination products to commercial sites (specification/method/equipment transfer)
* Translate internal and external cGMP and normative requirements (e.g., USP, Ph. Eur., ISO, ASTM) in applied operational processes incl. application thereof. This includes the following activities (among others):
* 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
* Support development of rationales justifying chosen approaches (e.g. acceptance criteria, statistical sampling, time points)
* Analyze test data (e.g., design capability, trending, k-value, reliability, DOE)
* Lead and track management of unplanned events (e.g., discrepancies, complaints) for these medical devices/combination products within cGMP regulated area)

Must Haves:
* Technical education, bachelor or advanced degree in Engineering or Science discipline (mechanical engineering / pharmaceutical / biomedical / materials science or a related field)
* 2-5 years track record and experience in practical testing and characterization of medical devices/combination products, primary packaging or pharmaceutical development (e.g., formulation, analyticspreferably for parenteral drug products
* 2-5 years track record and experience of working in pharma or other closely-regulated environment under cGMP or similar working practices
* Appropriate knowledge of legislation, regulation, industry standards and guidance around the area of medical devices / combination products
* Hands on expertise in: Functional / physical testing (e.g. container closure integrity, compression / tensile testing), dimensional measurements, jigs & fixture design
* Good knowledge of statistical techniques, risk management, root cause analysis
* Very good command of spoken/written English and German (min. B1)

Reference Nr.: 922634SDA
Role: Verification Engineer (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: ASAP (latest start date- 01/10/2023)
Duration: 12++
Deadline: 21.05.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.