A major pharmaceutical client are seeking a highly skilled and experienced Lead CQV Engineer to join their expanding team in Sydney due to recently winning a number of key projects. As the Lead CQV Engineer, you will be responsible for overseeing the commissioning, qualification, and validation activities of all pharmaceutical manufacturing processes and equipment. Your expertise will be crucial in ensuring compliance with regulatory standards, maintaining product quality, and driving operational excellence.
- Lead and manage the CQV team, providing technical guidance and support to ensure successful execution of all projects and activities.
- Develop and implement CQV strategies, plans, and protocols to ensure compliance with regulatory requirements, industry standards, and company policies.
- Conduct risk assessments and gap analyses to identify potential issues or areas for improvement in the CQV process.
- Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to coordinate and execute CQV activities.
- Develop and maintain CQV documentation, including protocols, reports, and standard operating procedures.
- Perform and oversee the execution of commissioning, qualification, and validation activities.
- Provide technical expertise and support for regulatory inspections, audits, and customer inquiries related to CQV.
- Stay current with industry trends, regulations, and best practices in CQV, and proactively identify opportunities for process improvements and innovation.
- Bachelor's degree in Engineering or a related field. Masters degree preferred.
- Minimum of 7 years of experience in pharmaceutical engineering with at least 5 years in CQV.
- Strong knowledge of regulatory requirements, as well as industry standards such as GMP.
- Proven experience in leading CQV activities for pharmaceutical manufacturing processes and equipment, including cleanrooms, HVAC systems, utilities, and packaging lines.
- Excellent understanding of validation principles and methodologies.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
- Detail-oriented, with a strong focus on quality and compliance.
- Ability to troubleshoot and solve technical problems, and to make sound decisions based on data analysis.
- Experience with regulatory inspections and audits is highly desirable.
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