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Job Description
Job Purpose
At Takeda, our purpose is Better Health, Brighter Future. The CSV Engineer reports to the Engineering Services Manager and is responsible for ensuring that all computerized systems meet validation, compliance, and regulatory requirements. This includes supporting site production and laboratory systems, CAPEX projects, and technology transfer initiatives while maintaining the highest standards of quality, safety, and integrity.
It is a full-time fixed-term (Maternity Cover for 12 months) position at our location in Grange Castle, Ireland.
How you will contribute:
Computerized System Validation (CSV)
- Plan, develop, review, and execute validation activities including URSs, DQ, FAT/SAT, IQ/OQ protocols and reports.
- Support ongoing CSV re-qualification programs and annual validation plans.
- Provide technical validation support to CAPEX projects and new system implementations.
- Review vendor documentation to ensure commissioning and qualification requirements are met.
- Supervise vendors and contractors during CSV-related activities as required.
- Identify and resolve validation deviations and non-conformances promptly.
- Maintain compliance with regulatory and industry standards, including data integrity and 21 CFR Part 11 considerations.
Cross-Functional & Operational Support
- Collaborate with cross-functional teams to support technology transfer and system implementation.
- Actively promote teamwork and integration across Engineering Services and other departments.
- Support department KPIs and contribute to continuous improvement initiatives.
- Participate fully in cross-functional training and knowledge-sharing activities.
Environmental Health & Safety (EHS)
- Ensure adherence to site EHS policies, procedures, and legislation.
- Promote a culture of safety awareness among personnel, contractors, and visitors.
- Ensure EHS compliance in commissioning, contractor management, and daily operations.
Training & Professional Development
- Prepare and deliver training materials as required.
- Ensure timely completion of all SOP training and assessments for self and others.
- Maintain and update professional knowledge, keeping up with industry trends and regulatory changes.
General Responsibilities
- Demonstrate Takeda-ism values in all activities and interactions.
- Contribute to a culture of continuous improvement, quality, and safety.
- Complete all required documentation, training, and assessments in a timely manner.
- Perform other duties as assigned by management or site leadership.
What you bring to Takeda:
Education & Experience
- Bachelor’s degree in Engineering, Science, or equivalent.
- Minimum 3 years’ experience in CSV within a pharmaceutical environment.
- Strong knowledge of validation practices, regulatory guidelines, and audits.
- Experience in writing validation plans, requirements gathering, system design, configuration, testing, and troubleshooting.
- Familiarity with Kneat Paperless Validation is advantageous.
- Knowledge of 21 CFR Part 11, ER/ES, and data integrity standards preferred.
- Experience in API, Drug Product, or Secondary Packaging manufacturing is advantageous.
- Ability to work in a regulated environment while driving continuous improvement.
- Excellent technical writing, organizational, and communication skills.
- Strong quality mindset and ability to collaborate across multiple departments.
- Self-motivated with the willingness to contribute beyond core responsibilities.
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!
Locations
Grange Castle, Ireland
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time
