Lead Validation Engineer
1 week 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 protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), along with comprehensive reports.
- Creates, reviews, and endorses validation documentation and Standard Operating Procedures (SOPs) within the department. Takes on a leadership role in validation project teams, steering the group's efforts towards achieving compliant solutions.
- Identifies opportunities for process enhancements and formulates proposals aimed at optimizing operations. Establishes standards for machinery and processes to improve overall equipment effectiveness.
Position Duties:
- Conducts thorough equipment validation, including IQ, OQ, and PQ, ensuring adherence to relevant regulations concerning equipment, processes, and systems.
- Essential: Familiarity with J&J Validation Methodology.
- Plans, organizes, and oversees validation projects, providing guidance, mentorship, and supervision to team members engaged in validation activities.
Core Competencies:
- Strong Communication Skills: Expected to provide regular updates to both internal and external stakeholders.
- Exceptional project management abilities with a proactive work ethic.
- In-depth validation knowledge in accordance with J&J guidelines and a comprehensive 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 a relevant field such as Science or Engineering.
- A minimum of 5 years' experience as a Validation Engineer in the medical device, pharmaceutical, or similarly regulated sectors.
- Expertise in all facets of IQ, OQ, PQ, and Process Development Validations, along with ISO 13485 compliance, demonstrating a solid understanding of FDA and MDD GMP standards related to medical devices and/or pharmaceuticals.
- Proven experience and knowledge in product verification and process validations, including software aspects.
- Desirable familiarity with Geometric Dimensioning and Tolerancing (GD&T), Six Sigma methodologies, and Statistical Engineering principles.
- Preferred: Knowledge of laboratory equipment.
This engineer will report to the LIMS Administrator, who oversees and supports the laboratory information management system, a software solution designed to assist laboratories in managing their workflows and data efficiently.
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