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.
Job Summary:
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.
Key Responsibilities:
- 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).
Qualifications:
- 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 [1] 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.
Benefits:
- 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.
