Senior Validation Expert

hace 1 mes

Manatí, Puerto Rico Validation & Engineering Group, Inc A tiempo completo
Job Description

Overview

Validation & Engineering Group, Inc. is a leading provider of solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries.

Role Summary

The Senior Validation Specialist will oversee validation activities for critical GxP-regulated systems, processes, and equipment used in manufacturing, laboratory, and quality control.

Main Responsibilities

  • Lead validation projects, including developing, executing, and reviewing protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.
  • Define validation strategies to ensure compliance and efficiency.
  • Oversight of biotech process and equipment validation, ensuring that all critical equipment meets regulatory and operational standards.
  • 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.
  • Ensure compliance with regulatory guidelines, including FDA 21 CFR Part 11, GAMP 5, and ICH Q9.
  • Cross-functional collaboration to align on validation requirements and support the successful implementation of new equipment, systems, and processes.
  • Manage deviations, change controls, and non-conformances related to validation activities.
  • Audit preparation and support: serve as a subject matter expert during internal and external audits.
  • Training and mentorship: train and mentor junior validation team members and system owners on validation processes.
  • Continuous improvement initiatives: drive projects to streamline validation processes, increase efficiency, and reduce validation cycle times while ensuring compliance and quality standards.

Qualifications

Bachelor's degree in Life Sciences, Engineering, or related field. Advanced degree (Master's or PhD) in Biotechnology, Biochemistry, or related field preferred.

Minimum of 5-7 years of experience in validation within the biotechnology or pharmaceutical industry, including hands-on experience with equipment, process, and computer system validation.

Expertise in GxP validation practices, including IQ/OQ/PQ for equipment, facilities, utilities, and computerized systems.

Deep knowledge of regulatory requirements and guidelines, including FDA, EMA, ICH Q9, GAMP 5, and other global standards for computer systems and process validation.

Strong analytical, problem-solving, and project management skills.

Ability to lead cross-functional teams, manage multiple projects, and communicate effectively with stakeholders at all levels.

Estimated Salary

$120,000 per year, depending on qualifications and location.

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