• To support manufacturing and laboratory operations calibration program in a prompt manner and take preventive measures to assure proper functioning of operational equipment ensuring compliance with Company standards and regulatory requirements.
• This position must follow all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Responsibilities:

• Verifies and/or calibrates instrumentation as needed per current CMMS System
• Documents Calibration process using current CMMS.
• Revises calibration sheets to ensure proper documentation, calculation and process completion.
• Modifies or update CMMS documentation as needed.
• Repairs instruments and equipment as needed.
• Uses several test equipment and tools (e.g., pressure, temperature indicators, etc.)
• Contacts supplier for quote external calibration of the instrument and standards
• Performs inventory of the standards in the calibration shop
• Initiates, takes part, and aids in resolution of quality investigations.
• Attends to all mandatory training for GMP’s EHS and company Policies.
• Attends to all mandatory meeting as staff.
• Revises, improves or create calibration procedures based on observation or current experience.
• Participates actively in special projects as needed.
• Troubleshoots manufacturing and utilities equipment.
• Participates and aid validation and qualification process.
• Writes and reviews SOPs for instruments and controls.
• Prepares reports and keeps records on calibration inspection, testing, and repair.
• Ensure low cost of the calibration department (Reducing overtime, implementing new ideas)
• Plans, justify and implement cost reduction small projects.
• Escorts vendor to perform equipment calibration.
• Writes and supports deviations and investigations that result from calibration, performance verification or maintenance activities, along with developing and supporting the implementation of corrective and preventive actions.
• Supports the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment.
• Executes requalification on Controlled Temperature Units (ex. Refrigerators, -20°C/-80°C Freezers, Incubators, Cryobanks, Croods, and Walk-In Cold Rooms)
• Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness, and compliance to Client standards.

Education qualifications:

• High school Diploma or Associates or Bachelor's degree

Experience:

• 3+ years of lab experience preferred in pharma or medical device industry or manufacturing.
  

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