Job TitleKey Responsibilities:Develop and execute CQV documentation including protocols (IQ/OQ/PQ), reports, risk assessments, and traceability matrices.Support or lead commissioning and qualification activities for equipment, systems, and utilities (e.g., HVAC, WFI, clean steam, autoclaves, filling lines).Coordinate with cross-functional teams including engineering, quality, production, and automation to ensure successful project execution.Perform data integrity reviews and ensure documentation complies with GDP (Good Documentation Practices).Ensure alignment with internal procedures and regulatory requirements (e.g., FDA 21 CFR Part 11, Annex 15, ASTM E2500).Participate in FAT/SAT testing and support deviation investigation, change control, and CAPA processes.Collaborate with project stakeholders to support facility startups and technology transfers.Maintain validation master plans (VMPs), schedules, and project status reports.Qualifications:Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Life Sciences.3+ years of experience in CQV roles in the pharmaceutical, biotechnology, or medical device industry.Strong knowledge of GMP regulations, validation life cycle, and quality systems.Experience with automated systems, data integrity principles, and GAMP 5 guidance.Proficiency in validation and risk assessment methodologies (FMEA, URS, DQ, etc.).Excellent organizational, technical writing, and communication skills.Preferred Skills:Experience with aseptic manufacturing and cleanroom environments.Familiarity with project management tools and systems (MS Project, Primavera, etc.).Lean Six Sigma or similar process improvement training.Ability to work in a fast-paced, dynamic project environment.