Process / Chemical Engineer

Company Overview:

We are a leading medical device company committed to developing innovative solutions that improve patient outcomes and enhance healthcare delivery worldwide. With a focus on cutting-edge technology and a dedication to quality and safety, we strive to advance the field of medical devices and make a meaningful impact on the lives of patients and healthcare professionals.

Key Responsibilities:

1. Validation and Process Optimization: Lead validation activities for manufacturing processes, equipment, and software systems, ensuring compliance with regulatory requirements and industry standards.
2. CAPA Management: Drive Corrective and Preventive Action (CAPA) initiatives, conducting root cause analyses, implementing effective solutions, and monitoring CAPA effectiveness to prevent recurrence of quality issues.
3. Sterilization Validation: Develop and execute sterilization validation protocols, including steam, ethylene oxide (EtO), and gamma radiation, to ensure the safety and efficacy of medical devices.
4. Compliance with Regulatory Standards: Ensure adherence to regulatory requirements and standards, including ICH, EN ISO13485, MDD 93/42/EEC, MDR, and ISO 10993, throughout the product development lifecycle.
5. Change Control and Life Cycle Management: Manage change control processes and life cycle management activities for medical devices, ensuring compliance with regulatory requirements and maintaining product quality and safety throughout the product life cycle.
6. Risk Management: Implement risk management strategies and methodologies, such as Failure Mode and Effects Analysis (FMEA), to identify and mitigate potential risks associated with medical device development and manufacturing.
7. Continuous Improvement: Drive continuous improvement initiatives to enhance manufacturing processes, optimize product quality, and reduce costs while maintaining compliance with regulatory requirements.
8. R&D Projects: Collaborate with R&D teams to support the development and commercialization of new medical devices, providing technical expertise and ensuring compliance with regulatory requirements.

Qualifications:

Minimum of a MSc in Chemical Engineering or related field. 4+ years of experience in validation, process engineering, or related roles within the medical device/pharma industry. Strong knowledge of CAPA processes, sterilization validation methodologies, and medical device development requirements. Familiarity with regulatory standards and guidelines, including ICH, EN ISO13485, MDD 93/42/EEC, MDR, and ISO 10993. Experience with statistical analysis, DOE, and risk management tools preferred. Excellent communication, problem-solving, and project management skills. Ability to thrive in a fast-paced, collaborative environment and drive results in a highly regulated industry.

How to Apply:

To apply for this exciting opportunity, please submit your resume and cover letter outlining your qualifications and relevant experience to [email protected]. We look forward to reviewing your application and considering you for this critical role in our organization. #LI-CH3 #LI-Remote #LI-Onsite