Validation Engineer

Flexible & Integrated Technical Services, LLC • Añasco, PR

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About The Position

This position is for a Validation Engineer specializing in Test Method Validation services within the Engineering area, specifically for the Pharmaceutical & Medical Devices Industry. The role involves identifying and implementing opportunities to optimize and improve manufacturing processes using engineering methods like Six Sigma and LEAN, designing and re-designing equipment and tools, and conducting complex experiments to qualify and validate manufacturing processes. Key responsibilities include analyzing and resolving manufacturing and compliance issues, developing training materials, leading project plans, overseeing manufacturing support tasks, and executing Test methods validation (ATMV / VTMV) for measuring equipment at the receiving inspection area. The company is a service provider that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services, focusing on employee well-being and providing quality talent to its clients.

Requirements

• Bachelor’s degree in Engineering
• At least seven (7) years of previous experience within the Pharmaceutical & Medical Devices Industry
• Bilingual: Spanish and English
• Excellent communication skills
• A positive attitude
• Experience in Validation methods
• Experience in Statistics
• Experience in Incoming and receiving processes
• Experience in Equipment validation and installation

Responsibilities

• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards mplex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
• Mainly, execute Test methods validation (ATMV / VTMV) for measuring equipments at receiving Inspection area.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees