Senior Documentation Engineer

Senior Documentation Engineer – Primary Packaging & Medical Devices – Product Care

We are currently assisting our client, a global leader in biopharmaceuticals, in their search for a Senior Documentation Engineer to join the Primary Packaging & Medical Devices – Product Care team in Bern, Switzerland. The company is committed to developing innovative therapies that improve patients’ quality of life and save lives. This role is critical for supporting lifecycle management of existing drug delivery technologies and ensuring compliance with regulatory standards.

The position focuses on design control documentation, risk management, and continuous improvement of primary packaging materials and medical devices for legacy products. The perfect candidate is a senior documentation engineer with 10+ years of experience in pharmaceutical device development, strong expertise in design control and regulatory compliance, and proven ability to manage lifecycle documentation for medical devices.

• Maintain design control documentation for legacy products.
• Incorporate market feedback (e.g., product technical complaints) into Design History Files (DHF).
• Support design modifications and ensure compliance with Health Authority requirements.
• Create, review, and approve design control documents (protocols, reports, risk management plans).
• Ensure compliance with ISO 13485, 21 CFR 820, ISO 14971, and EU MDR requirements.
• Coordinate cross-functionally to resolve quality issues and regulatory inspection findings.
• Promote data analysis using advanced statistical techniques and communicate results effectively.
• Ensure agreed targets for quality, timelines, and costs are met.

• Minimum 10 years’ experience in device development within a pharmaceutical company.
• Strong background in Change Control, Post‑Market Surveillance (ISO 14971, MDR, CAPA processes).
• Expertise in Design Control Documentation, Risk Management, and SOP writing.
• Proven ability to work independently and collaboratively across all organizational levels.
• Strong scientific knowledge of primary packaging and drug delivery systems.
• Excellent organizational and communication skills.
• Fluent English (German is an advantage).

Experience with lifecycle management and compliance projects in global pharma environments.

• Start date:
  
  01.01.2026
• Latest start date: 01.02.2026
• Planned duration: 12+ months
• Workplace:
  Bern, Switzerland
• Workload: 100%
• Home office:
  Up to 40% (Bern on‑site visibility minimum 60%)
• Team:
  Cross‑functional collaboration with Regulatory, QA, Manufacturing, Supply Chain
• Working hours:
  
  Standard