Validation and Quality Engineer

GENERAL DESCRIPTION:
Oversee the validation program, including scheduling, protocol development, sample collection, and evaluation, while ensuring compliance with regulatory standards. Manage the Calibration Program, IQ/OQ/PQ processes, and temperature mapping activities. Develop and maintain drug packaging procedures, ensuring alignment with industry best practices and cGMP guidelines. Follow up on and assist in the execution of corrective actions based on observations, ensuring timely resolution of non-conformances, identifying root causes, and implementing preventive measures to improve overall quality and compliance.

DUTIES/RESPONSIBILITIES:

• Prepare a plant-wide validation master plan, outlining timelines, resource allocation, and priorities for all validation activities.
• Supervise the execution of validation protocols, including protocol writing, sample collection, data analysis, and report generation.
• Ensure validation activities comply with industry standards, including FDA, EU GMP, and ISO requirements.
• Write and maintain detailed Standard Operating Procedures (SOPs) for validation and related processes.
• Ensure the collection and samples are analyzed during validation studies, test results are documented and preparing/review comprehensive validation reports.
• Maintain accurate and up-to-date records, including logbooks and validation tracking systems, and issue validation numbers.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) procedures for new and existing equipment and systems.
• Develop and implement cleaning and sanitation procedures for equipment, ensuring compliance with quality and regulatory standards.
• Coordinate with engineering and maintenance teams for equipment repairs, upgrades, and revalidation efforts.
• Plan and conduct temperature mapping studies for storage areas, refrigerators, and production environments.
• Oversee the maintenance and calibration of temperature mapping devices and monitoring systems, ensuring accurate and reliable performance.
• Evaluate and coordinate the purchase, installation, and validation of new temperature monitoring systems.
• Develop and execute a calibration program, ensuring all critical equipment and instruments are regularly calibrated and meet specified tolerances.
• Track calibration schedules, maintain calibration records, and manage external calibration service providers as needed.
• Create, review, and revise drug packaging procedures, incorporating changes in regulatory requirements and operational needs.
• Work with cross-functional teams to ensure packaging processes are efficient, compliant, and well-documented.
• Assist in the execution of corrective actions based on observations, ensuring timely resolution of non-conformances

QUALIFICATIONS / REQUIREMENTS:

• Sc. in Sciences; Computer competency required. SPC and Quality Principles an asset.
• 2 years experience in related field

SKILLS/KNOWLEDGE/LICENSES:

• Keep updated on current Industry, Governmental and Regulatory standards and initiatives
• Ability to deal well with customers, especially under pressure.
• High energy
• An in-depth understanding of what the customer’s requirements, balanced against what we can provide.

Full-time, Permanent

PLEASE NOTE: Only those we are interested in will be contacted.  Only submit one (1) application for this position.