Process Validation for Biological Safety
il y a 4 semaines
The Company:
The company is an innovative French company of 30 people specializing in the design and manufacture of orthopedic Medical Devices for extremity surgery. The expectations regarding practitioners' performance are constantly increasing, regulatory requirements are rising, and the optimization of technical platforms is a necessity. In this changing environment, their mission is to provide simple and innovative solutions to simplify surgical procedures and equipment management in the operating room, and to ensure the efficiency of surgical teams. They provide healthcare professionals with innovative solutions not only in product design but also in the use of new materials.
Main Mission:
Reporting to the Quality, Regulatory, and Clinical Management, you are responsible for:
- Leading actions related to the validation of processes known as "biological safety," including device cleaning, packaging, sterilization, and transportation,
- Leading biocompatibility studies of their products.
In this role, you will be required to:
- Develop Master Validation Plans (MVP) and update them as necessary,
- Define, write/verify process validation protocols,
- Organize the conduct of planned analysis tests and follow up with analysis laboratories,
- Implement statistical techniques necessary for data analysis,
- Write/verify process validation reports,
- Manage any non-conformity, deviation, CAPA files associated with validation activities,
- Participate in the management of suppliers involved in biological safety processes, particularly by drafting subcontractor specifications, conducting audits as a technical expert,
- Evaluate the impact of change files on validation files,
- Define validation strategies for ongoing development projects,
- Participate in process FMEAs,
- Develop biocompatibility study strategies for their products and organize test execution with laboratories.
Your Profile:
- With a Bachelor's degree in Engineering, Pharmacy, or equivalent,
- You have 3-5 years of professional experience in a similar position, imperative in the Medical Devices or Pharmaceutical industry.
- Required Quality/Competencies
- Ability to engage in your professional activity
- Good writing skills, in English
- Good knowledge of statistical methods applied to process validation.
- In-depth knowledge of regulations and standards associated with process validation (ISO13485, 21 CFR 820, ISO19227, ISO11607-1 and -2, ASTM D4169, ISO 11137-1 to 3, ISO 11737-1 and 2).
- You have perfect command of computer tools (Word, Excel, PowerPoint).
-
Staff Engineer Iii
il y a 4 semaines
Lyon, France MSA Safety Temps pleinOverview: Are you someone who is passionate, motivated, and driven to make a difference? If so, MSA Safety is the perfect fit for your career. At MSA, SAFETY is who we are AND it is what we do. We are a purpose-driven company committed to deploying innovation and technology to deliver on our Mission to help protect people and assets all around the world. We...
-
Process Engineer
il y a 4 semaines
Lyon, France Ahlstrom Specialties Temps pleinYou have a choice of where you want to work! Ahlstrom is uniquely positioned as the global leader in a broad range of sustainable and technically advanced specialty materials. Building further on our strong positioning offers an exciting opportunity to capture additional value from growing markets by combining our knowledge, innovation power and...
-
Enginering Support Operator
il y a 7 jours
Lyon, France MSA Safety Temps plein**Overview**: We are a technology company that aims to help people return home safely from their worksites by building smart safety systems. We have a hyper focused safety culture that puts our customers and our employee safety first. As a company, we aim for stable and sustained business growth and this strategy has supported our growth. We hire carefully...
-
Service Technician
il y a 7 jours
Lyon, France MSA Safety Temps pleinOverview: We are a technology company that aims to help people return home safely from their worksites by building smart safety systems. We have a hyper focused safety culture that puts our customers and our employee safety first. As a company, we aim for stable and sustained business growth and this strategy has supported our growth. We hire carefully to...
-
Process Engineer Trainee
il y a 4 semaines
Lyon, France Pharmaplan SAS Temps pleinPASSION FOR PHARMA ENGINEERING: This is what PHARMAPLAN stands for. As a leading engineering partner in Europe, we plan and implement integrated and holistic pharmaceutical production facilities for our industrial customers, providing future-proof solutions. As part of the TTP GROUP with over 1,100 employees and 29 locations in 6 countries, we place great...
-
Safety Designer Senior
il y a 4 semaines
Lyon 1er, France SERES TECHNOLOGIES Temps pleinDescriptif du poste Dans le cadre de nos activités de conception sûre des nouveaux systèmes de mobilité tels que bus électriques et/ou H2, camion H2, et de manière général tout engin motorisé par un GMP non conventionnel, nous recherchons un ingénieur fortement expérimenté sur les périmètres suivant: - Stockage énergie électrique (batterie...
-
Health, Safety and Environment Manager
il y a 7 jours
Lyon, France Club Med Temps pleinYou are - Attentive, you have a strong ability to listen and observe in order to make the right diagnosis. - Responsible, you advise our staff and customers, ensuring that they feel safe and secure. - As a decision-maker, your diagnosis leads to the implementation of your choices. You will - Support and monitor the implementation of SOPs and specific new...
-
Validation engineer and computer systems F/M
il y a 4 semaines
Lyon, France Audensiel Temps pleinValidation engineer and computer systems F/M Lyon, France Type contrat Full time Présentation de l'entreprise A multi-specialist player in digital transformation, business consulting and technology consulting, Audensiel supports its clients in all sectors of activity in France and internationally in the following areas: - Digital: digital...
-
Qualification/Validation Engineer F/M
il y a 2 semaines
Lyon, France Audensiel Temps pleinQualification/Validation Engineer F/M Lyon, France Type contrat Full time Présentation de l'entreprise A multi-specialist player in digital transformation, business consulting and technology consulting, Audensiel supports its clients in all sectors of activity in France and internationally in the following areas: - Digital: digital...
-
Innovation Process Manager
il y a 2 jours
Lyon, France Exertis Temps pleinKey responsibilitiesEstablishing a process and strategy for innovation – creation of ideas, establishing an innovation council and process for yielding candidates through to fast-fail or live and income generatingManage pipeline of live projects with stakeholders and scoring criteria similar to a Dragon’s Den or Shark Tank for innovationSupport and drive...
-
Post-Doctoral fellowship Miniaturized Chemistry
il y a 2 semaines
Lyon, France Bayer Temps pleinPost-Doctoral fellowship Miniaturized Chemistry - 18 months - (W/M) Post-Doctoral fellowship Miniaturized Chemistry – 18 months - (W/M) Informations: Contract type : Post-doctoral fellowship Duration : 18 months Localisation: Lyon 09 – Site of La Dargoire To be filled : As soon as possible The of Bayer is one of the world’s leading innovative...
-
Director, Financial Controller Emea
il y a 4 semaines
Lyon, France Maxeon Temps pleinPowering Positive Change In a world of constant change, the only way to make a meaningful impact is to stay ahead of the curve. That’s why at Maxeon Solar Technologies we’ve been pushing the boundaries of solar innovation every day for 35 years - from the very edge of outer space to countless rooftops below. Our highly advanced solar products are...
-
Post-Doctoral fellowship Miniaturized Chemistry
il y a 2 semaines
Lyon, Auvergne-Rhône-Alpes, France Bayer AG Temps pleinPost-Doctoral fellowship Miniaturized Chemistry - 18 months - (W/M) Post-Doctoral fellowship Miniaturized Chemistry – 18 months - (W/M)Informations: Contract type : Post-doctoral fellowship Duration : 18 months Localisation: Lyon 09 – Site of La Dargoire To be filled : As soon as possible The Crop Science Division of Bayer is one of the world's...
-
Post-Doctoral fellowship Miniatuarized Chemistry
il y a 2 semaines
Lyon, Auvergne-Rhône-Alpes, France Bayer AG Temps pleinPost-Doctoral fellowship Miniatuarized Chemistry - 18 months - (W/M) Post-Doctoral fellowship Miniatuarized Chemistry – 18 months - (W/M)Informations: Contract type : Post-doctoral fellowship Duration : 18 months Localisation: Lyon 09 – Site of La Dargoire To be filled : As soon as possible The Crop Science Division of Bayer is one of the world's...
-
Supply Chain Food Safety Auditor
il y a 7 jours
Lyon, France NSF Temps pleinNSF International Supply Chain Food Safety Auditor (NSF-SCFS) est connu comme un nom fiable en matière de sécurité alimentaire. NSF International aide les entreprises des secteurs de l’agriculture et de la transformation à maîtriser la sécurité et la législation alimentaire depuis plus de 70 ans. Notre vaste gamme de services de sécurité et de...
-
Distributions Quasi-stationnaires Pour Certains
il y a 4 semaines
Lyon, France Université Clermont Auvergne Temps plein**Distributions quasi-stationnaires pour certains processus de sauts // Quasi-stationary distributions for some jump Markov processes**: - Réf - **ABG-112369** **ADUM-47312** - Sujet de Thèse- 22/03/2023- Contrat doctoral- Université Clermont Auvergne- Lieu de travail- AUBIERE - France- Intitulé du sujet- Distributions quasi-stationnaires pour certains...
-
Operations Processes
il y a 4 semaines
Lyon, France Clasquin Temps plein**PASSION, ENTREPRENEURSHIP, RELIABILITY, PROACTIVITY, ACCURACY** Are you interested in working for a medium-sized international company specialized in freight forwarding, showing a clear strategy and double-digit growth for 20 years? Are you **reliable**, recognized for your excellent communication and analytical skills? Do you feel in line with our Motto:...
-
R&d Manager Process Development
il y a 4 semaines
Lyon, France AC CONSULTING Temps pleinPoste à pourvoir en SUISSE dans le canton du VALAIS As process development R&D Manager you will lead the Process Development Group within the R&D department. You will manage a team of 20 people (7 chemical engineers and 13 laboratory technician). You will manage directly the 7 chemical engineers. You will report at the R&D site director. **Your...
-
Senior Logistics Manager
il y a 1 semaine
Lyon, France CONMED Corporation Temps pleinAs a Logistics Manager at CONMED, you will be responsible for overseeing all aspects of warehouse operations to ensure efficient functioning and optimal utilization of resources for our French logistic organization with cross-functional support to our Regional EU DC. You will be tasked with managing inventory, supervising warehouse staff, and implementing...
-
Senior Logistics Manager
il y a 1 mois
Lyon, France CONMED Corporation Temps pleinAs a Logistics Manager at CONMED, you will be responsible for overseeing all aspects of warehouse operations to ensure efficient functioning and optimal utilization of resources for our French logistic organization with cross-functional support to our Regional EU DC. You will be tasked with managing inventory, supervising warehouse staff, and implementing...