Lead Validation Engineer
2 weeks ago
Key Responsibilities:
- This engineer is responsible for overseeing the validation processes of systems to ensure alignment with business objectives, user requirements, and regulatory standards. They will develop, document, and implement engineering studies, design experiments, and create Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols and reports. Additionally, they will review and endorse validation documentation and Standard Operating Procedures (SOPs) for the department. This role will also involve leading validation project teams to steer their activities towards compliant solutions. The engineer will identify opportunities for process enhancements and propose strategies for optimization. They will establish standards for machinery and processes to improve overall equipment efficiency.
Position Duties:
- Accountable for executing equipment validation processes: Installation, Operating, and Performance Qualification (IQ, OQ, PQ), ensuring adherence to validation regulations for equipment, processes, and systems.
- Must possess expertise in J&J Validation Methodology.
- Responsible for planning, scheduling, and managing validation projects. This includes providing leadership, mentoring, and oversight to team members and personnel engaged in validation activities.
Essential Competencies:
- Exceptional Communication Skills. The engineer will be required to provide regular updates to both internal and external stakeholders.
- Strong project management capabilities with a proactive work ethic.
- Extensive validation knowledge in accordance with J&J guidelines and a thorough understanding of Good Documentation Practices (GDPs).
- Proficient in computer applications.
- High standards of work quality and meticulous attention to detail.
- Outstanding planning and organizational skills.
Education & Experience Requirements:
- Bachelor's Degree in Science or Engineering.
- A minimum of 5 years of experience as a Validation Engineer in the medical device, pharmaceutical, or similarly regulated sectors.
- Experience in all facets of IQ, OQ, PQ, and Process Development Validations, as well as ISO 13485, with a solid understanding of FDA and MDD GMP regulations concerning medical devices and/or pharmaceuticals.
- Demonstrated knowledge and proficiency in product verification and process validations, including software.
- Desirable familiarity with GD&T, Six Sigma, and Statistical Engineering.
- Desirable knowledge of laboratory equipment.
This engineer will report to the LIMS Administrator, who oversees and supports a laboratory information management system. The LIMS is a software solution that assists laboratories in managing their workflows and data efficiently.
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