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Takeda Pharmaceutical Company Limited
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 on our four platforms:
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
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’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
The CSV Engineer reports to the Engineering Services Manager and will participate in:
All Computerised System Validation (CSV) activities on site, along with periodic requalification requirements.
Provide CSV support to capital projects that are executed on site.
The role requires a thorough understanding and experience of the validation requirements associated with a pharmaceutical manufacturing facility.
Support the CSV requirements for site production and laboratory systems.
Support the management of ongoing CSV re-qualification requirements.
Work cross functionally to develop and deliver the annual CSV re-qualification requirements.
Provide CAPEX team with adequate validation support at all times.
Review vendor documents to support commissioning and qualification requirements.
Completes the development, review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
Ensures validation non-conformances or deviations are minimised during execution of CSV activities. For issues that do arise ensure they are closed out in a timely manner.
Supervise vendors/ contractors on site as required.
Ensuring compliance with current industry regulations and guidelines relating to
validation.
Support department performance against defined KPIs.
As required, support the Technology Transfer initiatives for incoming new products.
Encourage actively the culture of teamwork and integration within the Engineering Services Department, and with all other Departments.
Participate fully in cross-functional training initiatives.
Participate in site EHS activities and ensure compliance with legislation and best practice.
Actively foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business.
Work with all GC personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.
Ensure compliance with legislative requirements as applicable to commissioning activities and contractor management.
Preparation and delivery of training material as required.
Ensure timely completion of all SOP training and assessment tasks.
Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures.
Maintain and improve their professional knowledge base. Keep up to date with all current trends and relevant legislation.
Participate fully in any cross functional training initiatives.
Drive and promote the corporate values of Takeda-ism within the workplace.
Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
Ensure timely completion of all SOP, reading, training and assessment.
Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
3rd level Engineering or Science Degree, or equivalent
At least three years validation experience (CSV) within a pharmaceutical setting.
Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.
Experience with regulatory audits, in particular representing computer system type issues.
Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
Experience working with Kneat Paperless Validation would be an advantage.
Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines would be an advantage.
Knowledge of working in any of; Active Pharmaceutical Ingredient manufacturing, Drug Product or Secondary Packaging would be an advantage.
The ability to work in a highly regulated industry and strive for continuous improvement.
Excellent interpersonal and communication skills.
Strong Quality orientation
Well organised and adaptable to change.
Excellent technical writing capability
Ability to work well with others across other departments.
Working knowledge of quality systems
Ability to work on own initiative.
Willingness to contribute beyond role specific duties and participate in site improvement initiatives.
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.
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.
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
Integrity
Fairness
Honesty
Perseverance
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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