Validation Specialist

Job Responsibilities:

• Oversee IQ/OQ/PQ for new instruments and maintain compliance with validation protocols.
• Draft, review, and approve CQV documents, including SOPs, calibration certificates, and validation reports.
• Manage cGMP and non-cGMP instruments across production, QC, and safety monitoring.
• Support facility sensors and controls, including HVAC, cleanrooms, and environmental monitoring.
• Develop system suitability protocols and assist with vendor qualification.
• Ensure on-time production and batch release by maintaining equipment reliability.
• Perform and oversee calibration, maintenance, troubleshooting, and servicing of instruments.
• Manage equipment warranties, preventive maintenance, and recalibration schedules.
• Maintain inventory of backup instruments, spare parts, and calibration supplies.
• Serve as an instrumentation expert, liaising with management and inspectors.
• Recommend equipment upgrades, software improvements, and process optimizations.
• Stay updated on FDA, USP/EP, ICH, PDA guidelines and implement change controls.
• Lead investigations and corrective actions for deviations, OOS, and equipment-related issues.

Qualifications:

• Bachelor’s degree in Chemistry, Engineering, or related field.
• 3-5 years of experience with laboratory instrumentation in a pharmaceutical setting.
• Experience in cleanroom operations, aseptic techniques, and environmental monitoring.
• Proficiency with HPLC, QC instruments, particle counters, lab balances, and pipettes.
• Strong problem-solving, time management, and attention to detail.
• Expertise in instrument calibration, maintenance, and troubleshooting.