Senior Validation Engineer

il y a 20 heures

Paris, Île-de-France KPC International Temps plein
Job Title: Senior CQV Engineer

KPC International is a leading provider of pharmaceutical and biopharmaceutical services, with a team of experienced engineers and scientists dedicated to delivering project success worldwide.

Job Summary

We are seeking a highly skilled Senior CQV Engineer to join our team, responsible for leading various projects validation programs, including commissioning and qualification, computerized system validation, and process validation.

Key Responsibilities
  • Accountability for various projects validation programs, including commissioning and qualification, computerized system validation, thermal validation, decontamination and 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
  • Establishes, generates, and maintains CQV department procedures in compliance with company and industry standards
  • Owns and maintains the validation program quality systems
  • Develops Validation Plans for validation projects and oversees contract staff, when necessary, through development of statement of work and vendor selection
  • Writes, reviews and approves associated commissioning, qualification and validation protocols and reports including executed protocols
  • Ensures appropriate resolution of protocol exceptions
  • Generates, reviews and approves CQV associated deviations, CAPAs
  • Performs/leads investigations and RCAs as required
  • Performs 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
  • 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 your experience, perspective and skills to help make an impact on the lives of others.

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