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JOB DESCRIPTION

JOB TITLE: Project & CQV Engineer (Internship)
REPORTS TO: Process Specialist and/or designee(s)

EDUCATIONAL REQUIREMENTS:

• Current participation in an Honors Engineering Degree (or higher), or related, discipline

RELEVANT EXPERIENCE:

• Previous experience in an engineering role is advantageous

SKILLS/COMPETENCIES:

• Excellent spoken and written English is essential.
• Excellent communication and interpersonal skills.
• Strong organizational skills.
• Excellent attention to detail.
• Ability to work under own initiative with some guidance.
• Well Motivated.

JOB PURPOSE:

To support and contribute to activities in the Project Engineering & Engineering Services (CQV) Departments. This brief demands flexibility and cross-functional liaison and co-operation, combined with competent technical ability.

RESPONSIBILITIES:

• Work with flexibility within the Project Engineering Department and in co-operation with other Departments.
• Support the project engineering team throughout the project lifecycle taking ownership for specific components of the lifecycle.
• Preparation of documentation as required during the project lifecycle
• Hands on contractor management during projects implementation stage
• Practical support of planning, execution and review of the projects planned to be undertaken during the annual maintenance shutdown event.
• Regular reporting of activities to direct line manager and working closely with same to achieve targets / objectives throughout the internship
• Develop and maintain a strong working relationship with all the departments’ customers both internally and across the site.
• Participate in Safety and Environmental training programmes and initiatives. Adhere to safe working practices as set out by the Safety Statement and other company safety rules
• Maintaining compliance with site procedures and policies
• Support Validation Maintenance Activities
• Qualifying equipment, critical systems (utilities), facilities, computerized manufacturing systems, cleaning processes and sterilization processes, as applicable
• development of protocols, coordination of validation activities, qualification/validation execution, preparing final reports and assembly of final validation packages; generation of project plans.
• Preparation, review and approve documentation for cGMP / Validation of the following:
• 
  
  
  
• Equipment, Facility, Utility

• Manufacturing Process
• Cleaning
• Computerized Systems and Automation Packages
• IT
• Support Validation maintenance activities – Requalifications and Periodic Reviews – Equipment, Facilities and Utilities

GENERAL RESPONSIBILITIES:

• Drive and promote the corporate values of Takeda-ism within the workplace.
• Ensure timely completion of all SOPs, reading, training and assessment.
• Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.