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Job Title: Validation Specialist
 
Date Posted: 03/31/25 Ref. Number: 435
Type: Full Time Part Time
Location: Sharon
Requirements: KNOWLEDGE, SKILLS AND ABILITIES:
• Bachelor’s degree in Science, Engineering or related field,
• Minimum 3 years’ experience in validation,
• Experience in Pharmaceutical, Biotechnology, Medical Devices or other GMP regulated industry,
• Proficient in Word, Excel, Outlook,

CORE COMPETENCIES:
• Excellent time management and organizational skills,
• Able to work under minimal supervision, as well as part of a team,
• Follow good documentation practices,
• High level of accuracy and attention to detail,
• Strong ability to communicate and collaborate as part of an established team,
• Work effectively in a fast-paced multi-tasking environment,
• Able to read, write and understand English.
Description: JOB SUMMARY:
The Validation Specialist will be responsible for execution of validations, analysis and review of validation data, validation report generation and calibrations. The Validation Specialist will report directly to the Quality Manager. This position will be located on-site in Sharon, ON.
DUTIES AND RESPONSIBILITIES:
• Perform and document validation activities for equipment and processes including IQ/OQ/PQ.
• Review and analyze validation data to ensure compliance with applicable standards.
• Conduct investigations and root cause analysis for deviations during validation.
• Set up test equipment and conduct tests on performance and reliability of mechanical, structural, or electromechanical equipment.
• Perform preventative and corrective maintenance of test apparatus and peripheral equipment.
• Perform calibration on test equipment or send for calibration and track and adhere to due dates.
• Perform and document risk assessments for equipment or processes
• Participate in writing SOPs, protocols and instrument validation plans.
• Implement and maintain effective calibration support processes.
• Adhere to all company policies and procedures including but not limited to the company manual, SOP policies and emergency action plan.
• Participate in health and safety training as required by the employer.
Hours per week:
Rate of Pay: