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- Aufgaben: Join us as a Validation Engineer, executing protocols and ensuring compliance in medical device manufacturing.
- Arbeitgeber: Work with a leading medical device manufacturer in the beautiful canton of Neuchatel.
- Mitarbeitervorteile: Enjoy a long-term temporary contract with opportunities for growth and skill development.
- Warum dieser Job: Make an impact in healthcare while working on exciting projects and collaborating with talented teams.
- Gewünschte Qualifikationen: Bachelor's degree in Engineering or Science with 2-5 years in Validation or Quality Assurance.
- Andere Informationen: Be part of FDA inspections and ISO certifications, enhancing your professional experience.
Das voraussichtliche Gehalt liegt zwischen 60000 - 84000 € pro Jahr.
I am looking for my client, a medical device manufacturer based in the canton of Neuchatel, for a Validation Engineer for a temporary (long term) contract.
Your responsibilities:
- Generation and execution of qualification/validation protocols including the generation, routing, and approval of summary documentation.
- Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
- Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
- Complete test method validation, gauges R&R studies, and other qualifications or studies to support product testing.
- Scheduling coordination, material allocation, and alignment of personnel in order to successfully complete validation assignments.
- Develop statistically based sampling plans for in-process and final test sequencing.
- Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO, or other applicable requirements.
- Support and address comments and suggestions associated with validation and engineering documentation.
- Protocol, Deviation, and summary report generation and approval.
- Change control, non-conformance, and CAPA support.
- Participate in FDA inspections, ISO certifications, surveillance audits, and customer audits.
Your profile:
- Bachelor’s Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
- 2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
- Demonstrates excellent organizational and communication skills.
- Experience with qualifying medical device manufacturing equipment.
- Excellent technical writing skills with a thorough understanding of good documentation practice.
- Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
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Validation Engineer - temporary contract Arbeitgeber: LHH
Kontaktperson:
LHH HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Validation Engineer - temporary contract
✨Tip Number 1
Familiarize yourself with the specific regulations and standards relevant to the medical device industry, such as cGMP, ISO, and QSR. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality.
✨Tip Number 2
Network with professionals in the medical device field, especially those who have experience in validation roles. Attend industry conferences or local meetups to make connections that could lead to job opportunities.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you successfully executed validation protocols or contributed to risk analysis. Highlighting these experiences can set you apart during the interview process.
✨Tip Number 4
Stay updated on the latest trends and technologies in validation engineering. Being knowledgeable about new methodologies or tools can show your enthusiasm for the field and your readiness to contribute effectively.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Validation Engineer - temporary contract
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the responsibilities and qualifications required for the Validation Engineer position. Tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 2 to 5 years of experience in validation or quality assurance roles, particularly in the medical device or pharmaceutical industry. Provide specific examples of your work with qualification protocols and risk analysis.
Showcase Technical Writing Skills: Since excellent technical writing skills are crucial for this role, include examples of documentation you have created, such as protocols, reports, or summaries. Make sure to demonstrate your understanding of good documentation practices.
Tailor Your Application: Customize your cover letter to reflect your passion for the medical device industry and your alignment with the company's values. Mention any experience with FDA inspections, ISO certifications, or audits, as these are relevant to the position.
Wie du dich auf ein Vorstellungsgespräch bei LHH vorbereitest
✨Understand the Regulatory Landscape
Familiarize yourself with cGMP, cGLP, QSR, and ISO standards. Being able to discuss how these regulations impact validation processes will show your expertise and readiness for the role.
✨Prepare for Technical Questions
Expect questions about your experience with qualification protocols and statistical methods. Be ready to provide specific examples from your past work that demonstrate your problem-solving skills and technical knowledge.
✨Showcase Your Communication Skills
Since the role requires collaboration with project teams, highlight your ability to communicate complex information clearly. Prepare to discuss how you've successfully worked with cross-functional teams in the past.
✨Demonstrate Organizational Abilities
Discuss your experience in scheduling and coordinating validation activities. Provide examples of how you managed timelines and resources effectively to meet project goals.
