We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Recruitment activities are focused on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.

For our client, the company CSL Behring, we are looking continuously for a

Device Development Engineer (m/f/d)

Description

CSL Behring AG in Bern specializes in the manufacture of drugs for the treatment of immune deficiencies and immune dysfunction, as well as drugs for rhesus prophylaxis and albumin solutions for shock and burn victims. CSL Behring AG's production facilities are licensed by the Swiss health authorities and the US FDA. Every year, therapeutically important proteins are isolated from over six million liters of human plasma in accordance with the strictest safety and quality standards and processed into medicines. The products of CSL Behring AG are distributed worldwide.

This Position is aligned with the strategic growth and restructuring of PPMD-PC (Primary Packaging and Medical Devices – Product Care) Team. This position will help execute on the strategic focus area’s for PPMDPC. The Position is responsible to support the selection, evaluation, improvement, qualification, implementation of new existing primary packaging materials, medical devices, and Combination Product for CSL Behring legacy products. The Position will provide scientific support to maintain the design of our existing commercially released Combination Products. Coordinate cross-functionally with Regulatory, Quality Assurance, Production, Manufacturing, and Supply Chain to provide post launch support, including design and supplier-related changes, product complaints, root cause analysis and other compliance projects. The Position executes projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices. Develop high-level plans, schedules, resource estimates, and budgets for projects under his/her responsibility. The Position will apply their knowledge of the regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDR requirements.

Working hours
Standard: 41h, Flexible working hours available

Tasks

Assure that design control is performed according to current scientific rational, regulatory /internal guidelines, legal requirements and quality standards. Ensuring data integrity and scientific consistency in all verification testing. Promote data analysis using advanced statistical techniques and communicate results to a crossfunctional team. Application of knowledge pertaining to regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, EU MDD/MDR requirements, compilation (and maintenance) of Design History Files, verification and validation and clinical trial/commercial manufacture support. Responsible for maintaining design control documentation for CSL Behring legacy products and incorporating market feedback, such as Product Technical Complaints, into the Design History File (DHF). Responsible for the documentation of new equipment as well as the maintenance of existing equipment. Ensure efforts related to design modifications to existing products follow the appropriate Design Control procedures as mandated by Health Authorities. Support with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions. Supporting the creation, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes. Compilation and maintenance of Design History File content and Conformity Assessments. Ensuring agreed targets for quality, timelines, costs, and user requirements are met. Provides effective and transparent communications to team members, colleagues, and other internal and external collaborators

Requirements

Minimum 10 years’ experience in Device Development at a Pharma Company which cover heavily involved in Change Control and Post-Market Surveillance (ISO 14971, MDR, CAPA processes). Focus on lifecycle management of existing products – ensuring compliance, continuous improvement Proven ability to work closely and efficiently with employees and colleagues of all levels as well as proven ability to be independent and self-motivated, demonstrating strong organizational and communication skills. Strong scientific background in all aspects of primary packaging and drug delivery. Experience with Design Control Documentation, Risk Management and SOP writing

Are you interested?

Then Mr. Raphael Sigg looks forward to receiving your complete application documents (CV, certificates and training certificates).

We look forward to hearing from you.