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Job Description

Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a CQV Engineer.

Takeda’s presence in Ireland was established in 1997 and our Irish operations have played a key role in our global leadership in rare diseases, oncology and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology.

About the role:

The CQV Engineer reports to the Engineering Services Manager and will participate in:

  • All Commissioning, Qualification and Validation (CQV) activities for Facilities, Utilities and Equipment (FUE) systems on site, along with equipment re-qualification requirements.

  • Provide CQV support to locally managed capital projects that are performed on site.

We are looking for a deep experience of the validation requirements associated with a pharmaceutical manufacturing facility.

How you will contribute:

  • Support the commissioning, qualification and validation of all process equipment, facilities and utilities on site.

  • Help manage ongoing equipment re-qualification and periodic review requirements.

  • Develop and deliver annual equipment re-qualification requirements.

  • Provide CAPEX team with validation support.

  • Review vendor documents to support commissioning and qualification requirements.

  • Complete the review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.

  • Ensure validation non-conformances or deviations are minimised during execution of CQV activities. For issues that do arise ensure they are closed out promptly.

  • Oversee vendors/ contractors on site during commissioning activities.

  • Ensure compliance with current industry regulations relating to qualification and validation.

  • Support department performance.

Environmental Health and Safety

  • Participate in site EHS activities and ensure compliance with legislation and best practice.

  • Foster an ethos and culture of safety awareness, where safety is accepted as an necessary part of the business.

  • Work with all site personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are observed across the site on an ongoing basis.

Training

  • Preparation and delivery of training material.

  • Ensure completion of all SOP training and assessment tasks.

What you bring to Takeda:

  • 3rd level Engineering or Science Degree, or equivalent

  • Experience with regulatory audits, in particular representing facility equipment qualification type issues.

  • At least three years validation experience (CQV) within a pharmaceutical setting with experience in computer system validation (CSV) an advantage.

  • Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.

  • Experience writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting

  • Experience in Kneat Validation Software desirable.

What Takeda can offer you:

  • Competitive salary and performance-based bonus

  • Employer retirement plan contributions

  • Employee Stock Purchase Plan

  • Revenue approved profit share scheme

  • Employer funded income protection

  • Employer funded private medical insurance with dependants’ cover

  • Employer life insurance contributions

  • Electric charging points available at parking locations

  • Employee Assistance Program

  • Wellbeing and engagement teams

  • Takeda Resource Groups

  • Flexible working arrangements

  • Family friendly policies

  • 26 vacation days plus additional days for service milestones

  • Coaching and mentoring

  • Educational programs and formal training

  • Development opportunities

  • Humanitarian volunteering leave options

  • Subsidized canteen (only for Bray and Grange Castle)

  • Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals


More about us:

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.

Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change, and innovation. Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years.


How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, 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 living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Deadline: 10-04-2024

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