Overview: The Validation Specialist is responsible for planning, developing, and implementing validation protocols and documentation to ensure compliance with regulatory standards across equipment, processes, and systems. Key Responsibilities: Develop and execute change controls, validation plans, and protocols (FAT/SAT/IQ/OQ/PQ/CSV). Conduct statistical analysis and design sampling plans for testing and inspections. Review and approve validation documents and reports. Troubleshoot validation issues related to equipment or processes. Recommend improvements during validation execution. Support validations related to packaging equipment, freeze-drying systems, water and steam systems, clean rooms, and laboratory equipment. Investigate and document non-conformances and deviations.
Collaborate cross-functionally with internal departments, vendors, and regulatory bodies. Ensure compliance with FDA, ISO, OSHA, EPA, and GMP regulations. May be required to work extended shifts or non-standard hours. Qualifications: Bachelor’s degree in Engineering (Mechanical, Industrial, Electrical, Chemical, or Biomedical) or a related scientific discipline. Minimum 5–7 years of experience in the medical device/pharmaceutical industry, with at least 5 years in validation engineering. Experience with various validation types including packaging, cleaning, test method, computer systems, sterilization, utilities, and more. Knowledge of Lean/Six Sigma (Green/Black Belt preferred). Strong documentation skills and ability to lead cross-functional teams.
Fully bilingual with excellent communication skills.
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