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• Title: Senior Documentation Engineer
• Location: Bern, Switzerland
• Rate: Open
• Openings: 1
• Contract/Perm: 12 Months

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Job Purpose:

This position supports the strategic growth and restructuring of the PPMD-PC (Primary Packaging and Medical Devices - Product Care) team and contributes to the execution of key strategic focus areas.

The role is responsible for the selection, evaluation, improvement, qualification, and implementation of new and existing primary packaging materials, medical devices, and combination products for CSL Behring legacy products.

It provides scientific expertise to maintain the design integrity of commercially released combination products and coordinates cross-functionally with Regulatory, Quality Assurance, Production, Manufacturing, and Supply Chain teams to deliver post-launch support. This includes managing design and supplier-related changes, addressing product complaints, conducting root cause analyses, and supporting compliance projects.

The position ensures projects are executed within agreed timelines, quality standards, and cost constraints, resulting in state-of-the-art drug delivery devices. Responsibilities include developing high-level plans, schedules, resource estimates, and budgets for assigned projects.

The role applies knowledge of regulatory requirements to ensure compliant designs, adhering to Quality Management Systems such as ISO 13485 and 21 CFR 820 Design Control, risk management per ISO 14971, and EU MDR requirements.

Responsibilities:

• 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 analyses using advanced statistical techniques and communicate results to a cross-functional 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 covers:
• 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.

If you are having difficulty in applying or if you have any questions, please contact Emile De Beer at e.debeer@proclinical.com.

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