Validation Consultant/Talent Bank
- Puerto Rico
- Permanente
- Tiempo completo
- Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, and processes.
- Perform validation activities including qualification of facilities, utilities, equipment, and computerized systems.
- Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
- Collaborate with cross-functional teams including engineering, production, and quality departments to support validation efforts.
- Conduct risk assessments, deviations, and impact assessments to identify and mitigate potential issues.
- Prepare and review validation documentation such as protocols, reports, and standard operating procedures (SOPs).
- Troubleshoot and resolve validation issues to ensure timely project completion. Maintain up-to-date knowledge of industry trends, regulatory changes, and technological advancements in validation processes.
- Bachelor’s degree in Engineering or Science
- Minimum of 4+ years of experience in validation within a regulated industry (pharmaceutical, biotech, medical device, etc.).
- Strong knowledge of regulatory requirements (FDA, EU, cGMP) and validation best practices.
- Experience with validation of equipment, processes, and software systems. Proficiency in validation documentation and technical writing.
- Ability to work independently and collaboratively in a fast-paced environment.
- Excellent analytical and problem-solving skills.
- Strong attention to detail and organizational skills.
- Certification in Quality, Validation, or Regulatory Compliance (e.g., ASQ, CQE, etc.).
- Experience with software validation (CSV) and computerized system validation. Familiarity with automation systems and instrumentation. Knowledge of risk management tools such as FMEA (Failure Modes and Effects Analysis).