Senior CQV Engineer
il y a 1 semaine
KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.
We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.
We are always looking for experienced and talented Engineers to join our team here, so do reach out to us.
The Lead / Senior CQV Engineer will report to the Head of Global Engineering.
Job Responsibilities
- Accountability for various projects validation programs including: commissioning & qualification, computerized system validation, thermal validation, decontamination & sterilization validation, process validation, cleaning validation, transport qualification, aseptic process simulation and validation maintenance activities
- Performs strategic planning and development of activities for company CQV function, including compliance, capacity, timelines and directions
- Collaborates closely with senior leadership team in meeting corporate and organizational goals through establishing and reporting of department or organizational metrics
- Performs and ensures validation of GMP facilities through management of validation projects of various sizes while providing technical assistance. Acts as subject matter expert and resource to peers and colleagues
- Establish, generate, and maintain CQV department procedures in compliance with company and industry standards
- Owns and maintain the validation program quality systems
- Develops Validation Plans for validation projects and oversee contract staff, when necessary, through development of statement of work and vendor selection
- Write, review and approve associated commissioning, qualification and validation protocols and reports including executed protocols. Ensures appropriate resolution of protocol exceptions
- Generate, review and approve CQV associated deviations, CAPAs
- Perform/ lead investigations and RCAs as required
- Perform CQV associated change control assessments
- Primary point of contact for CQV associated audit requests
Requirements
- Degree in Life Sciences or related studies.
- Minimum of 6+ years in an engineering or a quality role in a cGMP related role with experience leading or direct people management.
- Fluency in French is essential
- Experience with DeltaV is essential
- Knowledgeable on cGMP manufacturing of investigational products and their associated requirements. appropriate to the current stage of the product lifecycle.
- Experience in facility design, qualification and start up.
- Ability to read/interpret engineering drawings and design documents.
- Good understanding of computerized system validation and data integrity principles.
- Strong technical writing abilities in being able to write from ground up SOPs and able to review as relevant to relevant ISPE/PDA, cGMP Guidelines and technical working documents.
KPC – International is an Equal Opportunity Employer who offers an inclusive environment where you can broaden you experience, perspective and skills to help make an impact on the lives of others.
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