Validation Specialist

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Validation Specialist (FTC 12 months)

About the Role:

The Validation Specialist supports small molecule validation activities, ensuring compliance with current regulations, guidelines, and Takeda quality standards. The role works closely with cross-functional teams to deliver process validation, cleaning validation, and continued process verification, contributing to operational excellence and regulatory compliance.

Responsibilities

• Support small molecule validation activities in compliance with regulations, guidelines, and Takeda quality standards
• Execute process validation, cleaning validation, and continued process verification
• Prepare, review, and execute validation documentation, plans, protocols, reports, and deviations
• Maintain policies, SOPs, and related documentation for manufacturing process and cleaning validation
• Act as validation representative in cross-functional project teams
• Support ongoing process control through data review, report generation, and implementation of control limits
• Review process-related change controls for validation impact
• Contribute to continuous improvement initiatives
• Support training of validation personnel and maintain SOPs, forms, and training materials
• Generate and maintain GMP-compliant documentation and review manufacturing and regulatory records
• Promote a strong safety culture and comply with all safety policies
• Complete all required training and maintain accurate training records

Skills & Qualifications

• Primary degree in a scientific discipline
• Minimum 2 years' experience in a validation role within a regulated environment (relevant equivalent experience considered)
• Strong technical understanding of manufacturing processes and equipment
• Knowledge of industry regulations and validation best practices
• Strong attention to detail and documentation skills
• Ability to work collaboratively across functions
• Commitment to safety, quality, and continuous improvement

What you can look forward to with us:

• Competitive Salary: Including performance-based bonuses.
• Retirement Plan: Employer contributions to your retirement plan.
• Comprehensive Insurance: Employer-funded private medical insurance with dependants' cover, life insurance, and flexible options like dental insurance, partner life insurance, and serious illness protection.
• Electric Charging Points: Available at parking locations.
• Employee Assistance Program: Support for personal and professional challenges.
• Wellbeing and Engagement: Dedicated teams to support your wellbeing.
• Family-Friendly Policies: Supportive policies for a balanced work-life.
• Generous Vacation: 26 vacation days plus additional days for service milestones and humanitarian volunteering leave.
• Development Opportunities: Coaching, mentoring, educational programs, and formal training.
• Subsidized Canteen: Enjoy meals at a reduced cost.
• Flexible Benefits: Options like fuel card, bike to work, commuter ticket, and insurance deals.

More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

If you are interested in this opportunity, we look forward to receiving your application via our online tool