Full Job Description
The primary responsibility of this role is to assist with the IQ/OQ/PQ of new instruments/equipment in support of manufacturing operations
Responsibilities for the (CQV) Commission Qualification Validation Engineerinclude:
• Assist with the development of equipment validation protocols (IQ/OQ/PQ) for new instruments and ensure compliance with applicable regulations and guidelines.
• Conduct equipment validation testing and generate validation reports.
• Provide technical support to manufacturing personnel and troubleshoot any issues related to equipment performance or quality.
• Collaborate with cross-functional teams to ensure timely completion of validation activities.
• Participate in risk assessments and provide recommendations for risk mitigation.
• Assist with the development and implementation of standard operating procedures related to equipment validation and qualification.
• Stay up-to-date with industry trends and regulations related to equipment validation and qualification.
Qualifications for the (CQV) Commission Qualification Validation Engineer include:
• Bachelor's degree in Engineering or a related field.
• Minimum of 5+ years of experience in equipment commissioning and validation in a pharmaceutical or medical device manufacturing environment.
• Strong knowledge of applicable regulations and guidelines related to equipment validation (e.g., FDA, EU, ICH).
• Experience with IQ/OQ/PQ protocols, process validation, and risk assessment.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a cross-functional team
Compensation for the (CQV) Commission Qualification Validation Engineer include:
• Compensation Range is dependent upon experience
• Comprehensive benefits package
Keywords
GMP, Pharmaceutical Manufacturing, Equipment Qualification, Equipment Commissioning, Equipment Qualification, IQ/OQ/PQ, Comprehensive Benefits Package, Health, Vision, Dental.
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