Senior Validation Engineer

Proclinical is seeking a Senior Validation Engineer to join a dynamic team.
The successful candidate will play a crucial role in ensuring that equipment, utilities, and systems within a biotech facility are qualified and maintained according to regulatory standards.
This role involves coordinating with internal teams and external contractors to manage validation processes and maintain compliance.Responsibilities:Develop and maintain validation plans and procedures for equipment qualification.Write and execute qualification protocols and generate reports.Coordinate scheduling, execution, and review of qualification protocols and reports.Manage vendors and contractors for qualification activities.Oversee projects related to computerized equipment and system validation.Conduct data integrity assessments and equipment requalification.Ensure compliance of equipment and building monitoring systems.Provide impact assessments for change controls and deviations.Troubleshoot equipment and system failures.Participate in project teams for new equipment and facility expansions.Support non-conformance investigations and change control activities.Assist with internal and regulatory audits and inspections.Maintain GMP-compliant training.Key Skills and Requirements:Professional experience in validation, engineering, or operations.Familiarity with cGMP environments and GMP utilities and equipment.Experience with data integrity assessments and computerized system validation.Strong communication and interpersonal skills.Attention to detail, flexibility, and technical writing proficiency.Knowledge of cGMP and GDP requirements.Ability to work independently and as part of a team.