Senior Documentation Engineer
Vor 7 Tagen
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. Responsibilities 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. Your profile 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). Nice to have Experience with lifecycle management and compliance projects in global pharma environments. Additional Information 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 #J-18808-Ljbffr
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Senior Medical Device Documentation Engineer
Vor 3 Tagen
Bern, Schweiz Proclinical Staffing VollzeitA leading recruitment agency is looking for a Senior Documentation Engineer in Bern, Switzerland. This role demands a minimum of 10 years' experience in Device Development, focusing on regulatory compliance and documentation management for legacy products. The successful candidate will ensure adherence to quality standards, engage in cross-functional teams,...
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Senior Documentation Engineer — Pharma Packaging
Vor 7 Tagen
Bern, Schweiz LHH VollzeitA global leader in biopharmaceuticals located in Bern is seeking a Senior Documentation Engineer for its Primary Packaging & Medical Devices team. The ideal candidate will have over 10 years of experience in device development and expertise in design control documentation and regulatory compliance. Responsibilities include maintaining design control...
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Senior Documentation Engineer
vor 2 Wochen
Bern, Bern, Schweiz Hays Vollzeit CHF 150'000 - CHF 180'000 pro JahrSenior Documentation Engineer – Primary Packaging & Medical Devices (m/f/d)Location:Bern, SwitzerlandStart Date:January 2026Duration:12 months, with option for extensionAre you an experienced professional in documentation and design control for medical devices and primary packaging?This is your opportunity to join a strategic project in a dynamic...
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Senior Documentation Engineer – Pharma Devices
Vor 7 Tagen
Bern, Schweiz LHH VollzeitA biopharmaceutical leader in Bern is seeking a Senior Documentation Engineer for 12+ months to maintain design control documentation and ensure compliance with regulatory standards. The ideal candidate has over 10 years of experience in device development, excels in Change Control and Post-Market Surveillance, and has strong organizational and communication...
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Senior Documentation Engineer
Vor 7 Tagen
Bern, Schweiz Proclinical Group VollzeitA leading life sciences recruiter is looking for a Senior Documentation Engineer in Bern, Switzerland. The role requires at least 10 years of experience in device development at a pharma company, focusing on change control and post-market surveillance. Candidates must have a strong scientific background and be able to collaborate efficiently at all...
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Senior Documentation Engineer
Vor 7 Tagen
Bern, Schweiz LHH VollzeitClient Description 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....
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Senior Documentation Engineer
Vor 3 Tagen
Bern, Schweiz Proclinical Staffing VollzeitDirect message the job poster from Proclinical Staffing Are you ready for a change? Tired of the same routine? Join our team and make your mark in the industry! Have a look below and apply or send me your CV directly. Title: Senior Documentation Engineer Rate: Open Openings: 1 Contract/Perm: 12 Months Please note that to be considered for this role you must...
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Senior Documentation Engineer
Vor 7 Tagen
Bern, Schweiz Proclinical Group VollzeitAre you ready for a change? Tired of the same routine? Join our team and make your mark in the industry! Have a look below and apply or send me your CV directly. 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...
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Bern, Schweiz Hays VollzeitSenior Documentation Engineer – Primary Packaging & Medical Devices (m/w/d) Freiberuflich/in temporärer Festanstellung für ein Projekt Bern Startdatum: sofort Referenznummer: /1 Diesen Job teilen oder drucken Aufgaben Unterstützung bei Auswahl, Qualifikation und Implementierung von neuen sowie bestehenden Primärverpackungsmaterialien, Medizinprodukten...
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Senior Documentation Engineer
vor 2 Wochen
Bern, Bern, Schweiz CTC Resourcing Solutions Vollzeit CHF 120'000 - CHF 180'000 pro JahrSenior Documentation Engineer - Primary Packaging and Medical Devices ADAOur 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...
