API Process Development Engineer

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 API Process Development Engineer for 18 months.

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 :

As a leader of the API Technical Transfer “Project” the candidate is responsible for

• Ownership of the tech transfer production schedule
• Ensuring schedule adherence through appropriate communications across other departments; QA, QC, Logistics, Manufacturing Science.
• Appropriate understanding of regulatory requirements.
• Provide technical support and direction to manufacturing personnel ensuring batches and Plant Turnarounds are executed in an efficient manner.
• Ownership of the engineering and process validation runs.
• Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services.
• Investigate quality events as they arise and prepare deviation reports using site Trackwise system.
• Participate in CAPEX projects associated with P2, providing process knowledge input.
• Complete required documentation relating to development and manufacturing activities in an accurate and timely manner. Such documentation would include (but not be limited to) BMRs, SOP and Logbooks

General Role Responsibilities:

• Support a culture of open communication, fairness and transparency.
• Available to participate in ‘on call’ program and respond to ‘call out’ as required.
• Participate in any required training and ensure team members are suitably trained.
• Drive a continuous improvement mindset in line with AGILE programme at TILGC.
• Uphold Company Code of Conduct.
• Ensure that they themselves perform all operations in accordance with TILGC quality standards, GWPs, cGMPs and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.
• Foster a safe work environment, ensuring all colleagues maintain safety as a priority.
• Participate fully in any cross functional training initiatives.
• Foster, in cooperation with other TIL staff, an ethos of continuous improvement where CI 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 Manager, Finance or other Officer appointed by the Board of Directors.

What you bring to Takeda :

• 3rd Level Degree in Engineering or other relevant course.
• Minimum 4 years experience in Pharma Manufacturing including Technical Transfer
• Experience API small molecule operations would be beneficial
• Excellent written and verbal communication skills
• Flexible, willing and positive attitude / mind-set
• Excellent planning, scheduling and prioritisation ability
• Excellent documentation skills and attention to detail.
• Excellent knowledge of Microsoft products and systems skills.
• Strong Quality orientation.
• Ability to work under pressure & managing conflicting tasks at the same time.
• Attention to detail is critical.
• Ability to work well with others to achieve organisational goals.
• Safety focused.

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.

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