On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients across our platforms.
Small Molecules
Biologics
Plasma
Job ID: R0174927Location: Grange Castle, IrelandDate posted: 02/24/2026
This is a full‑time fixed‑term (maternity cover for 12 months) position.
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, supporting site production, laboratory systems, CAPEX projects and technology transfer initiatives while maintaining the highest standards of quality, safety, and integrity.
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.
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.
Benefits
Competitive Salary; performance‑based bonuses.
Retirement Plan with employer contributions.
Comprehensive Insurance: private medical insurance with dependants’ cover, life insurance, flexible options (dental, partner life, serious illness).
Electric charging points at parking locations.
Employee Assistance Program.
Well‑being and engagement support.
Family‑friendly policies for a balanced work‑life.
Generous vacation: 26 days plus additional days for service milestones and humanitarian volunteering leave.
Development opportunities: coaching, mentoring, educational programs, and formal training.
Subsidised canteen.
Flexible benefits: fuel card, bike‑to‑work, commuter ticket, insurance deals.
About Takeda
Takeda is transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programmes. As a patient‑focused company, Takeda 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. We foster an inclusive, collaborative workplace, united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
We are proud of our commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants 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.
Apply now via our online tool!
#J-18808-Ljbffr