Senior Documentation Engineer
vor 4 Wochen
Client 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. 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 #LI-Hybrid #J-18808-Ljbffr
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Senior Documentation Engineer
vor 3 Stunden
Bern, Bern, Schweiz LHH VollzeitClient Description:We are currently assisting our client, aglobal leader in biopharmaceuticals, in their search for aSenior Documentation Engineerto join thePrimary Packaging & Medical Devices – Product Careteam in Bern, Switzerland. The company is committed to developing innovative therapies that improve patients' quality of life and save lives.This role...
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Senior Documentation Engineer – Pharma Devices
vor 4 Wochen
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 4 Wochen
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 4 Wochen
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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Senior Analog IC Layout Engineer
vor 3 Stunden
Bern, Bern, Schweiz IC Resources VollzeitI am recruiting for a Senior Layout IC Engineer on behalf of my client, a long-established semiconductor company based in the Canton of Bern in Switzerland. This is a stable and technically engaging environment where engineers work across the full IC development cycle.The Senior Layout IC Engineer will act as the key link between internal design engineers...
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Senior DevOps Engineer
vor 3 Stunden
Bern, Bern, Schweiz Noir VollzeitSenior DevOps Engineer – Digitale Lösungen im öffentlichen Sektor – Bern / Hybrid(Schlüsselkompetenzen: DevOps, Microsoft Azure, Kubernetes, CI/CD, Infrastructure as Code, Terraform / Bicep, Automatisierung, Cloud Security, Azure DevOps, Linux, Python / Bash, Observability, Microservices, Agile Methoden, Sichere Plattformen)Sind Sie ein erfahrener...
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Senior Network Operations Engineer
vor 3 Wochen
Bern, Schweiz Swatch Group Services VollzeitSenior Network Operations Engineer The companyWe don't exclusively manufacture legendary watches; We keep in time with technology! The Swatch Group Services Ltd. has an IT Competence Center for our 16 brands, that would make Tony Stark jealous. Are you ready to be our Tech Talent? Then keep reading! Live your passion in a position where you drive innovation,...
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Senior ICT-Test-Engineer
vor 2 Minuten
Bern, Schweiz Coopers Group AG Vollzeit................ Für unseren Kunden in Bern , suchen wir eine:n erfahrene:n, motivierte:n und aufgeschlossene:n Senior Test-Engineer . Deine Aufgaben: Analyse von Business Requirements und Ableitung von Testfällen und Testszenarien Planung und operative Durchführung von funktionalen, Integrations- und End-to-End-Tests Unterstützung und Durchführung von...
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Senior System Engineer – Infrastruktur
vor 3 Stunden
Bern, Bern, Schweiz Rocken® VollzeitUnser Partner steht für Information, Communication und Network und ist mit rund 30 Mitarbeitenden und sechs Standorten ein ständig wachsendes KMU im Bereich ICT. Sie bieten ICT-Komplettlösungen an - vom lokalen Server zur Telefonanlage oder eine Lösung aus der Cloud, zugeschnitten auf die Bedürfnisse der Kunden.RolleFür unseren Rocken Partner, einen...
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Senior Cloud Platform Engineer
vor 3 Stunden
Bern, Bern, Schweiz Noir VollzeitSenior Cloud Platform Engineer – SaaS – Bern / Hybrid(Key skills: Cloud Platform Engineering, Azure (or AWS/GCP), Kubernetes, DevOps, Infrastructure as Code, CI/CD, Automation, Cloud Security, Azure DevOps, Python / Bash, Microservices, Monitoring & Support, Agile, Cross-Functional Collaboration)Are you a highly experienced Cloud Platform Engineer with a...
