Job Description
About the role:
This position is a fixed-term role for 12 months.
As a CQV Engineer at Takeda, you will play a key role in ensuring the safe, compliant, and efficient introduction and qualification of facilities, utilities, and equipment (FUE) systems on site. Reporting to the Engineering Services Manager, you will support all Commissioning, Qualification and Validation (CQV) activities, as well as ongoing equipment re-qualification and capital projects. Your expertise will help us maintain the highest standards of quality and compliance in our pharmaceutical manufacturing environment.
How you will contribute
- Support commissioning, qualification, and validation activities for process equipment, facilities, and utilities on site.
- Manage ongoing equipment re-qualification and periodic review requirements.
- Develop and deliver annual equipment re-qualification programs.
- Provide validation support to the CAPEX project team.
- Review vendor documentation to support commissioning and qualification activities.
- Prepare, review, and execute validation deliverables (validation plans, URS/DQ/FAT/SAT/IQ/OQ protocols and reports).
- Minimise validation deviations during CQV activities and ensure timely closure of any issues.
- Oversee vendors and contractors during commissioning activities.
- Ensure compliance with industry regulations and current validation guidelines.
- Actively contribute to continuous improvement and departmental performance.
Environmental Health and Safety (EHS)
- Participate in site EHS activities and ensure compliance with legislation and best practice.
- Promote a culture of safety awareness across all site activities.
- Collaborate with colleagues, contractors, and visitors to ensure full adherence to EHS policies and procedures.
Training
- Prepare and deliver training materials as required.
- Ensure timely completion of all SOP training and related assessments.
What you bring to Takeda
- Bachelor's degree in Engineering, Science, or a related discipline (or equivalent qualification).
- Minimum of three years' CQV experience in a pharmaceutical environment; CSV experience is an advantage.
- Strong knowledge of validation practices and regulatory requirements in the pharmaceutical industry.
- Hands-on experience in preparing validation plans, gathering requirements, design documentation, system configuration, testing, and troubleshooting.
- Experience with regulatory audits, especially in relation to equipment qualification.
- Familiarity with Knead Validation Software is desirable.
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
Top Skills
What the Team is Saying
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world.
We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.
Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.
Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Takeda's hybrid policy varies by role. Be sure to ask your recruiter about the requirements for the role that you are applying for.
