Sr Validation Subject Matter Expert – Computer Systems Validation, Japan New Plasma Facility Project

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Job Description

About Takeda

”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

OBJECTIVES/PURPOSE

A Computer System Validation (CSV) engineer is responsible for ensuring that computerized/automation systems used in the manufacturing, testing, and distribution of pharmaceutical products are validated and comply with regulatory requirements. The CSV engineer works closely with cross-functional teams, including manufacturing/production, IT, quality assurance, and regulatory affairs, to develop and execute validation plans, protocols, and reports.

ACCOUNTABILITIES

Acting as Computer Systems Validation (CSV) engineer in the Engineering workstream of the project, he/she will:

• Report to the CQV Lead/Validation Manager.
• Develop and execute validation plans, protocols, and reports for computer systems.
• Ensure that computer systems are compliant with regulatory requirements, including FDA regulations, GxP guidelines, and industry standards.
• Collaborate with cross-functional teams to identify and mitigate risks associated with computer systems.
• Conduct risk assessments and develop risk mitigation strategies for computer systems.
• Develop and maintain standard operating procedures (SOPs) for computer system validation.
• Provide training and guidance to end-users on the proper use of computer systems.
• Participate in audits and inspections to ensure compliance with regulatory requirements.
• Keep up-to-date with industry trends and best practices related to computer system validation.
• Manage vendors/contractors related to CSV activities.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BA or BS degree preferably in the engineering or science field.
• 5+ years of validation experience for non mgr role.
• Experience in validation of GMP manufacturing process control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens)
• Experience in control systems validation as part of a large capital project (e.g. new facility installation) is a plus.
• Experience in Plasma manufacturing is a plus.
• Prior experience in use of KNEAT (paperless validation system) in a validation project is a plus.
• Prior experience interacting with the FDA and other regulatory agencies.
• Excellent verbal and written communication skills in English and Japanese.

What Takeda can offer you:

Allowances: Commutation, Housing, Overtime Work etc.

Salary Increase: Annually

Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/Yamaguchi) 8:00-16:45, (Narita) 8:45-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

Flexible Work Styles: Flextime, Telework

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