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Process Development Engineer

Takeda Pharmaceutical

Ireland
2 days ago
Ireland
2 days ago

Job Description

  • Lead a cross-functional team during technical transfers (sending site) and new product introduction (NPI) (receiving site) projects in accordance with a pre-approved project plan, schedule and current project management best practice.  Ensure that critical manufacturing systems and support structures are in place for major technology transfer and NPI projects and provide technical advice on process engineering requirements as needed.  Liaise with technology transfer project counterparts in other Takeda sites;
  • Project manage the technical transfers to ensure a smooth transition;
  • Execute early stage feasibility, technical, process optimisation and process validation studies;
  • Liaise with the Engineering Process Support Team to identify process improvement opportunities for legacy products.  Propose and implement sustainable solutions to reduce processing times, improve yield, reduce defects and eliminate waste;
  • Identify cost-effective opportunities for the introduction of best-in-class manufacturing technologies. Design and introduce these technologies to manufacturing operations;
  • Review Change Records and Risk Assessments to assess potential process and validation impact;
  • Use statistical software packages for data analysis and in the identification and reporting of shifts, signals and trends in process parameters and product quality attributes;
  • Execute process improvement projects and deviation investigations using Six Sigma methodologies;
  • Liaise with other departments, vendors, external consultants & other Takeda sites as required;
  • Provide regular progress updates (written and verbal) on projects and activities within and beyond the Manufacturing Sciences Team as stated in project communication plans and/or as required by the relevant stakeholders;
  • Adhere to the compliance matrix of business processes and routine departmental tasks;
  • Comply with the relevant industry and Company quality standards and the cGMP pertaining to pharmaceutical production;
  • May be required to assume responsibilities of Process Support Engineer where applicable, from time to time and as directed by the Manager or Director.
  • 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.
  • Degree qualified in a Science or Engineering discipline;
  • Masters in a related field is preferable.
  • Ideally 3 - 5 years’ experience as a Process Engineer with Pharmaceutical industry and New Product Introduction project experience;
  • Operations, process / technical support, projects or validation-based experience of oral solid dosage manufacturing processes an advantage;
  • Experience with technical transfers (sending site) for pharmaceutical products an advantage.
  • Excellent communication, report writing, presentation, interpersonal and time management skills.

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time
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Validation Engineer/ Technical Specialist

Tandem Project Management

Cork, Cork
4 days ago
Cork, Cork
4 days ago

Summary:
Our client, a global Bio pharma company based in Cork is looking for a Validation Engineer who will collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, investigations, change control) in the vaccine manufacturing to ensure the effective and efficient on-time delivery of these activities for the vaccine manufacturing.

Responsibilities:

  • Ensure the highest Quality, Compliance and Safety standards primarily not only with Technical/Validation activities but relating to all activities to enable the team’s performance in the Vaccine Technical group within the vaccine manufacturing.
  • Project validation support including conducting equipment performance qualifications (cleaning and sterilization validation periodic reviews, re-qualifications, temperature mapping).
  • Authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data.
  • Resolving technical issues encountered during study execution.
  • Lead and close process related deviations and reports and participate in problem solving teams across all areas of the vaccine manufacturing (e.g. reliability, Safety, Quality (e.g. CAPA/DN/MDNs etc).
  • Experience with audits and preparation for audits.
  • Responsible for the technical support of manufacture in the vaccine manufacturing.
  • Technical review, ownership of and approval of Global Change Management records as required.
  • Recommend technical approaches in line with global and local standards.
  • Contribute for driving a culture of Continuous Improvement by deploying Our Company Six Sigma tools and MPS within the team on projects such as: problem solving, reducing cycle time, lean principles within the new processes.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Qualifications & Experience:

  • Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional is desirable.
  • Evidence of Continuous Professional Development.
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Validation Engineer (Pharma)

Sigmar

Cork, Cork
20 days ago
Cork, Cork
€60k - €80k Per Year
20 days ago
€60k - €80k Per Year

Validation Engineer (Pharma)

Looking to join a well-established pharmaceutical company? One of Ireland’s leading healthcare companies is looking for a Validation Engineer to join their team on an 11-month contract in Cork.  

Job responsibilities:

  • Ensure highest Quality, Compliance and Safety standards primarily Technical/ Validation activities
  • Project validation support including conducting equipment performance qualifications (cleaning and sterilization validation periodic reviews, re-qualifications, temperature mapping)
  • Authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data
  • Experience with audits and preparation for audits
  • Technical review, ownership of and approval of Global Change Management records as required

Job requirements:

  • Minimum 2 years validation experience
  • Hons Degree or Masters in a Science or Engineering discipline
  • Preference for Lean Six Sigma qualifications

If you would like to discuss this job, please reach out to Louise Whitty on 021 2359140 /

lwhitty@sigmar.ie

REF ValCorkM895959

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

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Sterilisation Validation Engineer I

Sigmar

Galway City, Galway
25 days ago
Galway City, Galway
25 days ago

Sterilisation Validation Engineer I | 18Month Contract | Galway.

Our client, one of Galway’s leading Medical Device company are looking for a Sterilisation Validation Engineer to join their team on an 18-month contract.

You will be working within the Sterilisation Validation Department where you will be focusing on product quality and work alongside Sterility Assurance for New Product Development. 

Initially for this role you will be remote. 

You will be responsible for:

  • Supporting Sterility Assurance activities for new products and change controls at both design and manufacturing sites.
  • Partake in root cause investigations and continuous improvement in your daily activity and initiate appropriate corrective actions and follow through to implementation.
  • Support EU MDR project work for Sterilisation Validation team.
  • Help support cross functional teams in design protocols to make sure that new products/ product changes are evaluated/ tested to guarantee compliance to all regulatory standards.
  • Support projects in internal and external audits and with submission preparation while also addressing any questions around these submissions.
  • Perform calculations, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.
  • Deliver on projects assigned and works with other stakeholders to achieve desired results within defined timeframes.
  • Adhere to all relevant site wide procedures and practices for Safety & GMP.

Your experience:

  • Degree (Level 8) qualification in relevant technical discipline such as Science or Engineering.
  • 2 years’ experience with Sterilisation Validation or Biocompatibility is preferred.
  • Excellent understanding of GMP and documentation required.
  • Can work effectively and proactively as an individual or on cross functional teams

 

 

If you are interested in this role please apply with an updated CV to Rebecca O'Connor at

ROconnor@sigmar.ie

 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

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Senior Quality Engineer

Webrecruit Ireland

Limerick, Limerick
24 days ago
Limerick, Limerick
24 days ago

Senior Quality Engineer

Limerick, Co. Limerick

 

The Company

 

Fleming Medical is a market-leading pharmacy supplies company based in Limerick which has grown internationally by design innovation in consumer healthcare products.

 

They are now seeking a Senior Quality Engineer to join their team in Limerick.

 

The Benefits

 

- Competitive salary

- VHI cover

- 20 days’ holiday

- Join a successful regulated medical device and healthcare distribution business

 

This is the ideal role for a quality-focused professional with an excellent grasp of quality assurance and regulatory standards to advance their career with a growing and highly successful organisation.

 

You will have the chance to play a pivotal role in building the company’s operational excellence across a diversified product portfolio.

 

So, if you want to support the delivery of pioneering products that are helping healthcare professionals across the globe to save lives, our client wants to hear from you.

 

The Role

 

As the Senior Quality Engineer, you will be tasked with driving compliance and continuous improvement of the site quality management system to the required quality and regulatory standards.

 

Driving compliance with activities such as new product introduction, supplier quality, change control, complaints, NC & CAPA, you will also seek to drive improvements to meet KPIs.

 

Managing and controlling document with the QMS, you will seek to improve QMS documents and systems, co-ordinate internal audits and identify and implement operational improvement initiatives.

 

Additionally, you will:

 

- Drive Quality requirements related to New Product Introduction

- Continuously assess the regulatory impact on new product releases or product updates

- Maintain appropriate product records to demonstrate compliance

- Develop appropriate trending analysis and sampling plan reviews

- Prepare for and participate in external regulatory inspections

 

About You

 

To be considered as a Senior Quality Engineer, you will need:

 

- Good knowledge of quality assurance and regulatory standards

- Good technical writing skills and experience

- Good computer skills including knowledge of Microsoft, ERP and QMS database systems

- Good communication and interpersonal skills with the ability to communicate clearly and concisely in both spoken and written form

- Attention to detail and accuracy to deal effectively with literature and data reviews

- To be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements

 

A third level qualification in a related discipline would be beneficial to your application, as would experience working in a similar quality assurance related role in the Medical Device Industry.

 

Other organisations may call this role Quality Engineer, Manufacturing Compliance Engineer, QA Engineer, Quality Assurance Engineer, QMS Engineer, or Compliance Engineer.

 

Webrecruit Ireland and Fleming Medical are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.

 

To apply for the role of Senior Quality Engineer, please apply via the button shown. This vacancy is being advertised by Webrecruit Ireland Ltd. The services advertised by Webrecruit Ireland Ltd are those of an Employment Agency.

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Validation and Quality Engineer

Sigmar

Waterford, Waterford
10 days ago
Waterford, Waterford
10 days ago

Are you a Validation and Quality Engineer? Would you like to be part of an ever-growing team that understands the importance of on-time delivery and support to their customers while also providing high quality, reliable, and compliant products? Then this might be the role for you!!

Job Responsibilities

  • Create concise and accurate on-time technical reports.
  • Create and evaluate metrics to drive quality improvements.
  • Determine root cause of problems using CAPA/8D/A3 Problem Solving.
  • Lead and conduct internal audits.
  • Lead risk assessments (FMEA)
  • Develop validation documentation-plans protocols, procedures.
  • Track and resolve deviations.
  • Compile relevant documentation from suppliers for inclusion in validation protocols and reports.
  • Assist in the development of training material for qualification activities.

Job Role

  • Level 8 in the relevant field.
  • Experience in validation of manufacturing processes and clean room environment.
  • 5+ years’ experience in a Production environment
  • 5+ years’ experience in Quality department
  • 5 years Customer complaints management experience
  • GMP experience
  • ISO 9001-13485 CFR 820 knowledge

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

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Quality Engineer

LSC

Cork, Cork
2 days ago
Cork, Cork
2 days ago

Quality Engineer - Medical Device - Cork
LSC have a great contract opportunity for a Quality Engineer to join a multinational medical device company based in Cork.
If you have 2 years experience in a medium to high volume manufacturing environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
o Team member representing the Quality function supporting projects in Materials Development with a focus on metals forming processes.
o Support Quality and Validation activities for product transfers and new product introductions.
o Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
o Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
o Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).
o Determine process inputs and factors for variation where process capability is required.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
o BSc in Engineering or Science with 2 years experience in a medium to high volume manufacturing environment
o 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO)
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Katie Brown at LSC on 021-4777329 if you have anymore questions about this Quality Engineer opportunity!
ABOUT LSC - CONTRACTING WITH A DIFFERENCE
LSC work exclusively in the Life Science sector and have designed a Consultant Success Programme to help make the contracting process as easy and rewarding as possible for all our consultants....visit www.lscconnect.com to find out more
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QA Engineer

Permanent

Dublin, Dublin
1 day ago
Dublin, Dublin
1 day ago

Do you want to work for a vibrant, exciting company operating in one of the fastest growing markets online today?

I am working closely with a leading multinational eCommerce company that provide an online marketplace which allows their users to access a vast range of royal-free digital media content.

Currently undergoing a period of growth, I am looking to speak with a talented, passionate and experienced QA Engineer to join this companies Software QA team in Dublin. The perfect candidate will have excellent testing skills, be detail oriented, and will thrive working in a highly technical environment.

This person will work across various teams using a number of tools and technologies and the company are looking for someone with a proven record in enabling the delivery of quality software and engaging throughout the full SDLC.

Duties of the role:

•Interact with PM and Dev teams to gain a strong understanding of the project and the testing objectives.
•Maintain and expand existing testing documentation for product and solutions.
•Work within an Agile environment (using JIRA).
•Protect the overall of quality, security and performance.
•Execute/analyse manual testing and write, execute, and maintain automated tests using the Robot Framework.
•Setup/maintain test environments.
•Support production deployment of applications.

What you need:

•1 - 3 years' experience in QA (at least 1 year to be within an agile environment).
•Excellent understanding of the full Software Development Lifecycle.
•At least 1 years' experience of automated web application test tools (Selenium, Protractor, Robot, etc).
•Knowledge of databases and writing SQL.
•Exposure to/experience in managing frequent releases.
•Excellent communications skills.
•Exposure to PHP, Postgres, Linux implementations (Desirable).
•ISTQB Certification (Desirable).

Please apply at the link provided or contact me for more information on this role and the fantastic package on offer! Call 087 695 0048 or email niall.gormley@stelfox.com

Please note:
We have a number of similar positions currently, and in the future, which we would like to discuss with you should you indicate your interest in this role. When we receive your application for this role, we will contact you to advise you of our process for other similar positions.
Stelfox is fully compliant with GDPR regulations and you can read more in our privacy policy here: https://www.stelfox.com/privacy-policy-gdpr/
Your shared data will not be disclosed or transferred to a third party data controller or data processor located outside the EEA unless we have obtained your express consent.
We look forward to working with you.

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QA Engineer

Reperio Human Capital

Galway, Galway
2 days ago
Galway, Galway
€350 - €400 Per Day
2 days ago
€350 - €400 Per Day

QA Automation Engineer - Contract
We have a new and exciting opportunity for a QA Automation Engineer to join one of our exclusive clients.
In this role you will have the opportunity to work within an growing technology centre whilst working alongside colleagues on core products, on a global scale.
Requirements
  • Extensive Automation Experience
  • Selenium & JAVA
  • Regression Testing - Jenkins
  • BDD Framework Experience
  • Compiling Acceptance Testing
  • Smoke Testing / Regression Experience

Desirable
  • Performance Testing Experience.

Key Skills
  • Test Automation
  • Selenium

Benefits
  • Competitive Daily Rate (€350-€400).

For more information on this role, contact Gareth Irvine at Reperio. Alternatively, please send your CV through the link below.
Reperio Human Capital acts as an Employment Agency and an Employment Business.
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Validation Quality Engineer

Nordson

Boyle
10 days ago
Boyle
10 days ago

Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.

Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart.Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL workswithdoctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond. 

Job Summary

For our Nordson Medical team in Boyle, Ireland, we are looking for a Quality Validation Engineer. As Quality Validation Engineer you will have the responsibility for the effectiveness of assigned areas of the company’s quality system and for completing validations of process and products as required. You will also provide validation and manufacturing quality support to the new product introduction manufacturing teams. Championing a structured approach to problem solving  and error proofing using 6 sigma  and lean principles.Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with Nordson quality system and the requirements of ISO13485, The Medical Device Regulation and FDA Quality System Regulations.

Duties and responsibilities

  • Champion the validation system, including maintenance and continual improvement of the validation process in line with regulations and industry best practice;

  • Provide support to the NPI engineers and sales to define validation plans and times to meet customer and Nordson Medical requirements;

  • Provide manufacturing quality engineering support for new product introductions and product changes to improve quality through improved processes and process control;

  • Assess customer’s validation needs and propose innovative solutions.Assess customer’s validation needs and propose innovative solutions;

  • Investigate, trouble shoot, disposition and report on validation failures, system failures, non conforming products  and other product defects. Champion a structured approach to problem solving within process improvement teams.

Education and Experience Requirements

  • A primary degree in engineering or equivalent.; A qualification in quality management is desirable;

  • Must be commercial, understanding the revenue generating aspects of small business and the cost implications of providing technical and validation solutions, in a timely manner.

Skills and Abilities

  • Strong analytical communication, organisational and influencing skills;

  • Ability to work hands-on, with a solid engineering background, engaging cross-functional groups, equipment and material vendors to resolve technical issues;

  • Energetic and driven self-starter, with good communication and influencing skills and the ability to effectively simultaneously manage a wide range of diverse activities;

  • Liaise with customers, being available to support sales, from a technical validation perspective.

Travel

  • < 1%; Only in cases when travel is needed to a customer or to other sites as required

Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.

Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart.Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL workswithdoctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond. 

Job Summary

For our Nordson Medical team in Boyle, Ireland, we are looking for a Quality Validation Engineer. As Quality Validation Engineer you will have the responsibility for the effectiveness of assigned areas of the company’s quality system and for completing validations of process and products as required. You will also provide validation and manufacturing quality support to the new product introduction manufacturing teams. Championing a structured approach to problem solving  and error proofing using 6 sigma  and lean principles.Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with Nordson quality system and the requirements of ISO13485, The Medical Device Regulation and FDA Quality System Regulations.

Duties and responsibilities

  • Champion the validation system, including maintenance and continual improvement of the validation process in line with regulations and industry best practice;

  • Provide support to the NPI engineers and sales to define validation plans and times to meet customer and Nordson Medical requirements;

  • Provide manufacturing quality engineering support for new product introductions and product changes to improve quality through improved processes and process control;

  • Assess customer’s validation needs and propose innovative solutions.Assess customer’s validation needs and propose innovative solutions;

  • Investigate, trouble shoot, disposition and report on validation failures, system failures, non conforming products  and other product defects. Champion a structured approach to problem solving within process improvement teams.

Education and Experience Requirements

  • A primary degree in engineering or equivalent.; A qualification in quality management is desirable;

  • Must be commercial, understanding the revenue generating aspects of small business and the cost implications of providing technical and validation solutions, in a timely manner.

Skills and Abilities

  • Strong analytical communication, organisational and influencing skills;

  • Ability to work hands-on, with a solid engineering background, engaging cross-functional groups, equipment and material vendors to resolve technical issues;

  • Energetic and driven self-starter, with good communication and influencing skills and the ability to effectively simultaneously manage a wide range of diverse activities;

  • Liaise with customers, being available to support sales, from a technical validation perspective.

Travel

  • < 1%; Only in cases when travel is needed to a customer or to other sites as required

Posted

2 days ago

Description

Job Description

  • Lead a cross-functional team during technical transfers (sending site) and new product introduction (NPI) (receiving site) projects in accordance with a pre-approved project plan, schedule and current project management best practice.  Ensure that critical manufacturing systems and support structures are in place for major technology transfer and NPI projects and provide technical advice on process engineering requirements as needed.  Liaise with technology transfer project counterparts in other Takeda sites;
  • Project manage the technical transfers to ensure a smooth transition;
  • Execute early stage feasibility, technical, process optimisation and process validation studies;
  • Liaise with the Engineering Process Support Team to identify process improvement opportunities for legacy products.  Propose and implement sustainable solutions to reduce processing times, improve yield, reduce defects and eliminate waste;
  • Identify cost-effective opportunities for the introduction of best-in-class manufacturing technologies. Design and introduce these technologies to manufacturing operations;
  • Review Change Records and Risk Assessments to assess potential process and validation impact;
  • Use statistical software packages for data analysis and in the identification and reporting of shifts, signals and trends in process parameters and product quality attributes;
  • Execute process improvement projects and deviation investigations using Six Sigma methodologies;
  • Liaise with other departments, vendors, external consultants & other Takeda sites as required;
  • Provide regular progress updates (written and verbal) on projects and activities within and beyond the Manufacturing Sciences Team as stated in project communication plans and/or as required by the relevant stakeholders;
  • Adhere to the compliance matrix of business processes and routine departmental tasks;
  • Comply with the relevant industry and Company quality standards and the cGMP pertaining to pharmaceutical production;
  • May be required to assume responsibilities of Process Support Engineer where applicable, from time to time and as directed by the Manager or Director.
  • 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.
  • Degree qualified in a Science or Engineering discipline;
  • Masters in a related field is preferable.
  • Ideally 3 - 5 years’ experience as a Process Engineer with Pharmaceutical industry and New Product Introduction project experience;
  • Operations, process / technical support, projects or validation-based experience of oral solid dosage manufacturing processes an advantage;
  • Experience with technical transfers (sending site) for pharmaceutical products an advantage.
  • Excellent communication, report writing, presentation, interpersonal and time management skills.

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time
Source: Takeda Pharmaceutical