Takeda
pharmaceutical
CSVEngineer(FTC12Months)
Neural analysis suggests this role is
optimal for Mid candidates.
“CSV Engineer (FTC 12 Months) at Takeda. Skills: Computerized System Validation (CSV), validation practices, regulatory guidelines, data integrity. 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”
What You'll Achieve.
Support department KPIs and contribute to continuous improvement initiatives
Industry & Context.
troubleshooting; Identify and resolve validation deviations and non-conformances promptly
What They're Looking For.
Must Have
Bachelor's degree in Engineering, Science, or equivalent, Minimum 3 years’ experience in CSV within a pharmaceutical environment, knowledge of validation practices, regulatory guidelines, and audits, Experience in writing validation plans, requirements gathering, system design, configuration, testing, and troubleshooting, Ability to work in a regulated environment while driving continuous improvement, Excellent technical writing, organizational, and communication skills, quality mindset and ability to collaborate across multiple departments, Self-motivated with the willingness to contribute beyond core responsibilities
Nice to Have
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
What You'll Do.
and execute validation activities including URSs
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
Ensure adherence to site EHS policies
Promote a culture of safety awareness among personnel
Ensure EHS compliance in commissioning
contractor management
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
Demonstrate Takeda-ism values in all activities and interactions
Contribute to a culture of continuous improvement
Complete all required documentation
and assessments in a timely manner
Perform other duties as assigned by management or site leadership
How You'll Work.
Team & Collaboration
Collaborate with cross-functional teams to support technology transfer and system implementation; Actively promote teamwork and integration across Engineering Services and other departments; Participate fully in cross-functional training and knowledge-sharing activities; quality mindset and ability to collaborate across multiple departments
Communication Scope
technical writing; communication skills
Process & Methodology
CAPEX projects, new system implementations, commissioning, contractor management
Full Job Description
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s [Privacy Notice](https://jobs.takeda.com/privacynotice) and [Terms of Use](https://www.takeda.com/terms-and-conditions/). I further attest that all information I submit in my employment application is true to the best of my knowledge. ## **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. * Suppor
Applying for this CSV Engineer (FTC 12 Months) role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Takeda?
Real rants from real employees. Read before you apply.