Process Engineering Manager(Closed)

Job Number: 658

External Description:

Position Summary & Job Description
 Ensure that all operation systems design, implementation and execution are compliant with applicable validation, cGMP, and regulations and requirements across Kujira campus. Areas of responsibility cover facilities and utilities, DQ, IQ, OQ, PQ, PPQ, cleaning, calibration, computerized systems, Lab and test method validation and qualification “on-site”
 Maintenance of team (10%): For execution of validation on-site, must establish team cross-functionally with internal resources and vendors
 Execution of validation on-site (60%): Focus on IQ, OQ, PQ and Cleaning validation for the time of being with full responsibility on Cleaning validation, preparation of SOPs and validation protocols are required.
 Act as DI manager (30%): On-site Computerized System Validation with full responsibility on CSV, preparation of SOPs and validation protocols as required.
 Provide advice in the introduction, coordination, monitoring and analysis of validation - and compliance processes
 Support colleagues and managers during visits, audits or contacts with Regulatory Agencies
 Training, specific theoretical knowledge and functional experience

Job Number: 658

Community / Marketing Title: Process Engineering Manager(Closed)

Location_formattedLocationLong: Shimotsuma Shi, Ibaraki JP