Validation Engineer

Flexible & Integrated Technical Services, LLC • Añasco, PR

2d • Onsite

About The Position

The Validation Engineer will provide Equipment Validation services specifically within the Analytical Laboratory area, primarily serving clients in the Pharmaceutical & Medical Devices Industry. The company is a service provider that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island and in the US. It prides itself on being flexible, family-oriented, and focused on its resources' well-being, while delivering top-quality talent to its clients.

Requirements

• Bachelor’s degree in Engineering or Chemistry.
• At least five (5) years of previous experience within the Pharmaceutical & Medical Devices Industry.
• Bilingual: Spanish and English.
• Excellent communication skills.
• A positive attitude.
• Experience in Validation of Laboratory Equipment.
• Experience with Analytical Balances.
• Experience in Software Validation.
• Experience in Preventive Maintenance.
• Experience in Technical Writing.

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.
• Conduct complex 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.
• Execute Analytical Laboratory Equipment and Methods Validations/Transfer.

What This Job Offers

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