Senior Documentation Engineer

Senior Documentation Engineer - Primary Packaging and Medical Devices ADA

Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare diseases.

We are seeking a highly skilled
Senior Documentation Engineer for their Primary Packaging & Medical Devices unit. It is an initial 12-month contract
position (with extension possibility) at our client's headquarters
in Bern
.

The purpose of the role:

• You will be responsible for supporting the
  selection, evaluation, improvement, qualification
  , implementation of new existing primary packaging materials, medical devices, and Combination Product for legacy products.
• You will
  provide scientific support to maintain the design of the 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.
• You will be responsible for executing 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 your responsibility.
• You will be required to apply your 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.

Main 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.
• Responsible for maintaining design control documentation for 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

Qualifications & Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• 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
  .
• Fluent in English, German fluency an advantage