Takeda Pharmaceuticals International AG

Job Description

Job/Position: CQV Engineer – Student Internship – Commissioning Qualification and Validation

BU/Organization: GMS / Small Molecule

Department: Engineering Services

OBJECTIVES/PURPOSE

There is a requirement to hire a Validation Technician to join the Bray Site Engineering Services Department to support the site Validation Maintenance activities along with supporting all validation activities related to the current and future pipeline of CAPEX and Continuous improvement projects including but not limited to:

• Process and Packaging Equipment (OSD)
• Facilities and Utilities
• Computerized Systems and Automation Packages
• Manufacturing and Packaging Processes
• Cleaning
• IT and Security
• This position is responsible for qualifying equipment, critical systems (utilities), facilities, computerized manufacturing systems, cleaning processes and sterilization processes, as applicable.
• Primary tasks include development of protocols, coordination of validation activities, qualification/validation execution, preparing final reports and assembly of final validation packages; generation of project plans.

ACCOUNTABILITIES

• Preparation, review and approve documentation for cGMP / Validation of the following: Equipment, Facility, Utility, Manufacturing Process, Cleaning, Computerized Systems and Automation Packages
• Support Validation maintenance activities – Requalifications and Periodic Reviews – Equipment, Facilities and Utilities
• Supports projects that require team participation. Must demonstrate competent and effective coordination, and organizational skills.
• Handles routine tasks with attention to detail, timely and accurately.
• Strong Technical writing abilities to support the preparation and review of Validation documentation (Risk Assessments, IQ, OQ, GMPAs, IOQRs etc)
• Initiation and management of change control records
• Participate and interface with cross-functional project team members representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements.
• Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards, procedures, and regulatory requirements.
• Evaluate quality standard of service providers for cGMP, including Validation requirements.
• Ensure up-to-date regulatory requirements for all validated operations
• Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA)
• Identify gaps related to validation requirements and Global Validation procedures.
• Participate, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions.
• Perform other duties as directed by supervisor
• Work with management and staff to foster an ethos and culture of cGMP & Quality awareness.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s degree preferably in Engineering or Science; and other job related experience.
• Strong attention to detail and accuracy.
• Strong interpersonal skills to support relationships with a number of stakeholders
• Familiarity with the CQV Lifecycle: validation documentation an advantage
• Familiarity with Quality Risk Management activities.
• Strong IT and computer skills – role will include use of multiple documentation management systems.