Validation Specialist

Job Description

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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 Validation Specialist for 12 month.

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.

How you will contribute :

Technology Transfer

• Play a leadership role in the introduction of a new process together with the preparation and execution of cleaning validation programs.
• Be the Subject Matter Expert in the cleaning validation aspect of the process including definition of cleaning program, assessment of key parameters and development of control strategies.
• Oversee changeover to a multi-product facility from a cleaning perspective.
• Preparation and execution of plans, protocols and reports associated with cleaning validation ensuring compliance with current industry regulations.
• Experience with process validation in a DP facility an advantage.

Quality Systems and GMP

• Perform operations in accordance with TILGC quality standards, current Good Manufacturing Practices (cGMP) and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.
• Complete required documentation in an accurate and timely manner. Such documentation would include (but not be limited to) records required by SOPs, Logbooks and Labels as well as HSE records.
• Generate documentation associated with their activities as required by cGMP and review Standard Operating Procedures (SOPs), Batch Manufacturing Instruction and Record (BMRs), Logbooks, Labels, In-Process Test documentation, and other regulatory documentation (Quality, Health & Safety, Environmental) as required.

Safety & Environment

• Actively foster, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
• Adhere fully to all safety policies, procedures and regulations.
• Notify the relevant Manager (or other appropriate responsible person) in a timely and comprehensive manner of any breach of HSE policy, procedure or regulation.

Training

• Actively participate in all training and assessment activities (internal and external) in relation to themselves, manufacturing personnel or other employees.
• 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.

What you bring to Takeda :

• Primary degree in a scientific discipline
• Experience of supporting a Drug Product Technology Transfer with a focus on cleaning validation.
• 5-8 years experience of working in a validation role in a regulated environment.
• Excellent knowledge of validation regulations and guidelines.
• A strong technical understanding of Drug product processes and equipment.
• Excellent verbal and written communication skills
• Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.

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
• 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.

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