Validation Specialist

hace 2 meses

Manatí, Puerto Rico Validation & Engineering Group, Inc A tiempo completo
About the Role

This is a key position within our company's Validation and Engineering team, where you will oversee and execute validation activities for critical systems, processes, and equipment used in manufacturing, laboratory, and quality control.

The Senior Validation Specialist will lead validation projects, develop strategies, and ensure compliance with regulatory standards such as FDA, EMA, and other global health authorities. Collaboration across departments is essential to implement best practices, troubleshoot complex issues, and support continuous improvement efforts in validation processes.

Key Responsibilities:
  • Validation Strategy and Execution: Develop, execute, and review protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, defining validation strategies to ensure compliance and efficiency.
  • Process and Equipment Validation: Oversee validation of biotech processes, equipment, utilities, and computerized systems, ensuring that all critical equipment meets regulatory and operational standards.
  • Risk-Based Validation Approach: Conduct risk assessments to prioritize validation activities based on potential impact to product quality, patient safety, and regulatory compliance.
  • Document Management: Develop, review, and maintain validation documentation, including validation plans, protocols, reports, and traceability matrices, ensuring all documentation is audit-ready and in line with regulatory expectations.
Requirements:

We are seeking an experienced professional with a strong background in GxP validation practices, including IQ/OQ/PQ for equipment, facilities, utilities, and computerized systems. Proficiency in validation lifecycle management and risk-based validation approaches is also required.

A Bachelor's degree in Life Sciences, Engineering, or a related field is essential, with advanced degrees preferred. A minimum of 5-7 years of experience in validation within the biotechnology or pharmaceutical industry is necessary, along with expertise in regulatory requirements and guidelines.

Strong analytical, problem-solving, and project management skills are essential, along with the ability to lead cross-functional teams and communicate effectively with stakeholders at all levels.

What We Offer:

We offer a competitive salary range of $120,000-$160,000 per annum, depending on experience, along with opportunities for professional growth and development.

Our company values diversity and inclusion, providing a collaborative work environment that fosters open communication and mutual respect. We prioritize employee well-being, offering comprehensive benefits, flexible working arrangements, and regular performance evaluations.

Location:

This role requires occasional travel to support validation efforts at different sites, but primarily involves office-based work and time spent in manufacturing or laboratory environments.

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