A leading innovator in the healthcare industry, dedicated to improving patient care and safety through cutting-edge medical devices. The company is committed to excellence in product development and quality assurance. The Validation Engineer will play a pivotal role in ensuring the reliability, safety, and compliance of the company's medical devices, contributing directly to its mission of enhancing healthcare outcomes worldwide.
The Validation Engineer is responsible for leading validation efforts for medical device manufacturing processes and product development. They will oversee a team of validation engineers and technicians, ensuring that all validation activities comply with regulatory standards and company policies.
- Develops and implements a comprehensive validation strategy for new product development, manufacturing processes, and equipment.
- Leads and mentors a team of validation engineers and technicians, providing guidance and support to ensure the successful execution of validation projects.
- Ensures compliance with FDA and other relevant regulatory requirements and standards (e.g., ISO 13485) to ensure all validation activities are in compliance.
- Creates, reviews, and maintains validation protocols, reports, and related documentation, ensuring accuracy and completeness.
- Conducts risk assessments to identify critical validation activities and establish risk-based validation priorities.
- Oversees the qualification of manufacturing equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- The Validation Manager should hold a bachelor's degree in engineering or a related field, with an advanced degree preferred.
- They should have a minimum of  years of experience in validation within the medical device or pharmaceutical industry.
- A strong understanding of FDA regulations and ISO standards related to validation is required.
- Proven leadership and team management experience is essential.
- Exceptional problem-solving and project management skills are expected.
- The Validation Engineer should be detail-oriented with a focus on documentation and compliance.
- They should possess excellent communication and interpersonal skills.
- Ability to work in a fast-paced and dynamic environment is necessary.
- Offers a competitive salary and performance-based bonuses.
- Comprehensive healthcare and dental plans are provided.
- A retirement savings plan with company matching is available.
- Generous paid time off and holidays are offered.
- Ongoing professional development opportunities are provided.
- The company fosters a collaborative and innovative work environment.