J-0336
製薬/バイオテック
Facilities / Maintenance Engineering・Manufacturing / Production
無料でご応募いただけます。3営業日以内にご連絡いたします。
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 in CAI 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.
• 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
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