Established in 1996, it has grown year over year to more than 850 people worldwide. It provides commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.

About the job

Our client is looking for an individual with a range of experience in the areas of commissioning, qualification, and validation to join our team in Japan. Experience in the pharmaceutical, medical device or biotechnology industries is required.


Position Description:

We are now seeking a Senior CQV Engineer to join our growing operations in Japan. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. He/She is responsible for protocol writing and execution, field verification, and development of summary reports at the client site.

The role of a Senior CQV Engineer is to:

• Independently develop documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
• Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.
  
  

Position Requirements

• BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
• 5 – 12 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
• Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
• Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
• High attention to detail
• Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
• Ability to work independently, while quickly building and nurturing a project team
• Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
• Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
• Experience in planning / directing C&Q activities
• Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
• Familiarity with Baseline Guide 5 (Second Edition) a plus
  
  

Other Requirements

• Expertise in Microsoft Word and Excel
• Excellent oral and written English are required.
• Able to travel if required
  
  

What we provide

• Competitive Salary
• Continuing education (internal and external)
• Opportunities to work on cutting edge projects in a highly evolving field