Validation Engineer - Umanist Staffing LLC

Overview

The Validation Engineer plays a crucial role in ensuring that all processes, systems, and equipment within the organization meet industry regulations and standards. They are responsible for conducting thorough tests and analyses to validate the functionality and performance of products, systems, or processes.

Key Responsibilities

Develop and execute validation protocols and reports for equipment and processes.

Perform risk assessments and impact analyses for validation activities.

Ensure compliance with regulatory requirements and industry standards.

Conduct validation testing, including installation, operational, and performance qualification.

Collaborate with cross-functional teams to identify and resolve validation issues.

Review and approve validation documentation and change control requests.

Participate in the development and improvement of validation procedures and best practices.

Provide technical support for validation-related activities.

Conduct training on validation procedures and requirements for relevant staff.

Perform periodic reviews and revalidation of processes and systems.

Investigate and resolve validation discrepancies and non-conformances.

Conduct validation assessments for new equipment and process modifications.

Stay updated on industry trends and regulatory changes related to validation.

Conduct validation audits and prepare for regulatory agency inspections.

Required Qualifications

Bachelor's degree in Engineering, Computer Science, or a related field.

Proven experience in validation and testing in a regulated industry.

Thorough understanding of regulatory requirements, such as FDA, ISO, and GMP.

Proficiency in documentation and record-keeping for validation activities.

Strong analytical and problem-solving skills.

Excellent communication and collaboration abilities.

Knowledge of quality assurance principles and practices.

Experience with statistical analysis and validation software/tools.

Ability to manage multiple projects and prioritize tasks effectively.

Detail-oriented with a focus on accuracy and compliance.

Ability to work effectively in a fast-paced and dynamic environment.

Certification in validation or quality-related disciplines is a plus.

Experience with validation of manufacturing processes is highly desirable.

Knowledge of risk management principles and methodologies.

Understanding of validation lifecycle and methodologies.