Process / Chemical Engineer
Location
India | India
Job description
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 - Validation and Process Optimization: Lead validation activities for manufacturing processes, equipment, and software systems, ensuring compliance with regulatory requirements and industry standards.
- 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.
- 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.
- 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.
- 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.
- 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.
- Continuous Improvement: Drive continuous improvement initiatives to enhance manufacturing processes, optimize product quality, and reduce costs while maintaining compliance with regulatory requirements.
- 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 [HIDDEN TEXT] We look forward to reviewing your application and considering you for this critical role in our organization.
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