Validation Engineer

Job Title

Key Responsibilities:

• Develop and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Coordinate and oversee the installation, testing, and validation of equipment and systems.
• Ensure compliance with regulatory guidelines (FDA, EMA, etc.) and industry standards (GMP, GxP).
• Prepare and review validation documentation, including Validation Master Plans (VMP), User Requirement Specifications (URS), and risk assessments.
• Perform validation activities for processes, systems, and equipment, including writing and executing test plans and reports.
• Identify and resolve deviations and non-conformities, ensuring timely corrective actions.
• Communicate effectively with clients, project teams, and stakeholders to ensure project objectives are met.
• Provide technical guidance and mentorship to junior team members.
• Contribute to the development and implementation of best practices and standard operating procedures (SOPs) in CQV activities.
• Stay current with industry trends, technological advancements, and regulatory changes.

Requirements:

• BS in Engineering, Science or equivalent technical degree.
• Solid understanding of GMP regulations and industry standards.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a dynamic team environment.
• Experience in commissioning, qualification, and validation within the pharmaceutical and/or medical device industry commensurate with the level of the project demand.
• Strong analytical and problem-solving skills with attention to detail.