Takeda

Takeda is a patient-focused, values-based, R&D-driven, global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Operating in over 80 different countries and regions, with a history spanning more than 240 years, Takeda’s vision is to discover and deliver life-transforming treatments, guided by our commitment to patients, our people, and the planet.

Takeda strives to create an exceptional people experience for patients, communities, partners, and employees, and is committed to fostering a culture of collaboration and innovation throughout the organization. We aim to create a diverse and inclusive organization where people can thrive, grow, and realize their own potential while enabling our purpose.

Our team of globally diverse colleagues are committed to making a positive impact on patients’ lives, driven by Takeda’s core values and mission. Through innovation, perseverance, and our people-focused approach, Takeda has been a global top employer for 6 consecutive years. We are seeking inspirational talent like you to support our goal of transforming into the most trusted, data-driven, outcomes-based biopharmaceutical company, in addition to our focus sustainability and embracing technology and the future.

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Career opportunities
These are just examples of the types of job opportunities the company offers. A complete overview of job opportunities can be found in the respective career portal

Engineering Services Manager

Maintenance Planner / Scheduler

Senior Process Engineer

Computer System Validation(CSV) Engineer

Senior Validation Engineer (major strategic project)

Quality Validation Engineer

Career Portal

Engineering at Takeda

Takeda’s team of global engineers are vital to the performance and daily operations of our Global Manufacturing Supply and Global Quality functions. Our success is driven by the hard work and dedication of our talented engineers that are responsible for designing and implementing cutting-edge technologies and processes that support our manufacturing and product operations.

Our engineers help shape every aspect of our product manufacturing. From designing and building fully automated filling lines to helping transition our sites to paperless validation and other digital solutions, our engineers are tackling some of the pharma industry’s most complex challenges.

Upgrading the level of automation at our sites and implementing advanced technology to improve reliability, compliance, and cyber security

Maintaining sustainable, reliable, and compliant operations for all 31 sites across the globe

Enabling the manufacturing of new products and supporting sites that are increasing capacity of existing products

Finding ways to minimize risks to the health and safety of our team members

Identifying ways in which we can contribute to climate protection and the conservation of our natural resources

Accelerating digital innovations to offer enormous opportunities that add value for our patients, people, and the planet.

An engineering career with Takeda offers complex challenges, innovation, problem-solving, and transformation, working towards our vision of widespread automation and digitalization. We offer the opportunity to make a significant professional and personal impact that will inevitably extend to improve the quality of life of our patients.

Engineering Services Manager

Location: Madrid, Spain

About the role

Based at our Cell Therapy plant in Madrid, reporting directly to Maintenance & Engineering Head, the Engineering Services Manager is responsible for:

  • Oversight of the Validation activities at Takeda Madrid Site qualification of equipment, critical systems/utilities, computerized systems, facilities, cleaning and sterilization process qualifications, analytical instrument qualification and transport validation.
  • Insurance of the maintenance of state of cGMP validation compliance.
  • Engineering compliance with regulations, Takeda policies, quality practices, and proper data and documentation control, including management of technical documents, layouts, manuals and others.
  • Represent Takeda Madrid Site during regulatory, corporate, division and third-party inspections; defend the validation program(s) to auditors and inspectors; support regulatory submission processes.
  • To lead Process Engineering program, according to global and local requirements for implementation.

How you will contribute:

  • Lead, coaching, providing direction and developing the performance of a diverse team of Pharmacists, Engineers and other Life science-related professionals, and develop employees and potential leaders, ensuring high performance, within the Team.
  • Represent the main figure/contact of Engineering Services Area with Engineering, Manufacturing, Regulatory Affairs, Quality Validation, Quality Operations, Quality Control, Quality Systems, and other departments.
  • Responsible for strategy definition and execution of routine and new project CQVs, covering C&Q of equipment, utilities, facilities and systems, CSV, transport, sterilization and cleaning validation, AIQ, ensuring compliance with FDA, EudraLex, Spanish, and other applicable GMP requirements.
  • Harmonization of validation activities with other sites (QMS, Communities of Practice, CoP´s).
  • Be a validation SME (subject matter expert) for validation and defend validation strategies, topics and documents during internal/external inspections.
  • Ensure compliance with regulations, Takeda policies, quality practices, and proper documentation.
  • Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable operation of systems.
  • Generation and driving of goals, reports, progress metrics, Department Boards to measure performance and Continuous improvement culture.
  • Lead for Engineering documentation management and control, EIMS, including technical documents, layouts and diagrams.
  • Lead for Process Engineering: Manage the Process Engineering staff, projects and support. Establish engineering discipline and practices that help operate manufacturing while improving process functionality.
  • Lead scope definition /clarification exercises to completely characterize process requirements.
  • Provide guidance and direction to employees and contractors to meet project and support schedules and financial goals while ensuring technical success.

What you bring to Takeda:

  • Minimum of a BS degree in Chemical, Biochemical or Mechanical engineering or equivalent
  • 10 years hands-on validation, engineering, and technical experience in a biopharmaceutical pharmaceutical production environment.
  • Minimum of 5 years of validation experience in writing, completing, and summarizing validation protocols and testing procedures on at least 3 of the next disciplines: CSV, C&Q, AIQ, Cleaning, Transport, Process, Methods or Sterilization.
  • Fluent Spanish and English (C1).

Skills and Competencies

Functional

  • Analytical skills
  • Will break down complex problems and tasks into activities that can be performed by personnel.

Technical

  • Broad and in-depth knowledge of current validation approaches, methods, and protocols to evaluate relevant biopharmaceutical/pharmaceutical equipment, systems, facilities and utilities.
  • Knowledge on Calibrations
  • Knowledge on equipment/systems qualification (HVAC, Cleanrooms, Gas systems, Controlled Temperature Units (CTUs) mapping, and Analytical Equipment qualifications.
  • Knowledge of FDA, ICH, EU, PDA, ISPE, ASME(BPE) and other global regulations and GMP guidelines associated with validation requirements
  • Experience with/participation in internal/external audits
  • Experience with protocol development, deviation identification and resolution, and summary/final report authoring. Experience performing statistical analysis of validation test results.
  • Sound industry knowledge and proficiency working in a project environment.

Behavioural/Interpersonal

  • Communicate effectively at all levels in verbal and written form, including technical/business writing.
  • Team player
  • Critical and inquisitive.

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.

Maintenance Planner / Scheduler

Location: Bray, Ireland

About the role:

  • Improve maintenance work force productivity and work quality by eliminating in advance potential delays, defects and obstacles through proper planning and coordination of maintenance activities, spare parts, machine time, craft and labor needs, safety measures
  • Efficient planning and scheduling of all maintenance work, including Calibrations
  • Coordinate between the manufacturing/production operations teams and maintenance organizations

How you will contribute:

  • Reporting directly to Maintenance, Facilities and Utilities Lead plans, schedules maintenance and calibration activities in the plant in collaboration with operations and maintenance supervisors
  • Prioritize current and latest work activities
  • Create and maintain work plans based on field reviews and expertise and parts assessments
  • Ensure accurate CMMS data
  • Monitor for problems and flow interrupters in the maintenance and calibration programs, and implements changes to lead performance improvement
  • Receive approved work requests from requesting departments, excepting emergency work
  • Review and screens each work request for completion. Discuss the details with the requestor as appropriate
  • Assure the work requested is needed and resolve
  • Convert Work Requests into Work Orders
  • Examines jobs to be done and determines best way to accomplish the work. Consult with requester, Maintenance Supervisor, Engineering or functional crews
  • Obtain blueprints, drawings, instructional manuals and special procedures. Make any additional sketches, diagrams, necessary to clarify the intent of the work order
  • Identify and obtain determinable materials and important items, entering material needs on the work order
  • Ensure safety needs are given a top priority in work planning
  • Estimates jobs with sequence of steps, the number of tradespersons and required labor hours for each step
  • Estimates cost of each work order regarding direct labor, materials required and total cost
  • Maintain backlog files of work orders waiting planning and scheduling following their priority limits with an estimated completion date
  • Verify the availability of parts, materials and special tools required for job execution before scheduling
  • Identify and generate each department's Preventive Maintenance workload
  • Review the schedule and labor availability forecasts weekly in preparation for the scheduling meeting
  • Attend production planning meetings and negotiate for downtime "windows" during which maintenance can be performed
  • Finalize schedules, ensuring that the work scheduled balances labor hours available so that a full day's work is provided each person
  • Coordinate requisition of all predetermined parts, materials and special tools and ensures that equipment to be worked on will be available
  • Review completed schedules and work orders submitted. Monitor work order progress
  • Develop a file of standard job plans for recurring repair jobs
  • Review the actual labor expended versus estimated labor and material used for completed jobs with Maintenance Supervisors and reports same to partners
  • Make recommendations for system improvements
  • Maintain necessary records, documentation and files and prepares accurate control reports
  • Support internal and external Audits and Inspections of the Maintenance Program
  • Support the sites AGILE (LEAN) program and improve of the EHS metrics for the department, including practical assistance where applicable
  • Develop collaboration with other sites within the Takeda network

Technical/Functional (Line) Expertise

  • Experience in planning relevant to an oral solid dose (OSD) pharmaceutical manufacturing plant
  • SAP experience
  • Understanding of cGxP regulations

Leadership

  • Must have exceptional organizational skills and ability to analyse and plan on the fly
  • Excellent communication and influencing skills
  • Strong project management skills

Decision-making and Autonomy

  • Prioritize the critical few and assigns work appropriately
  • Is courageous in making trade-offs when needed

Interaction

  • Engineering, Maintenance, Manufacturing/Production, Utilities Operations, Instrument Calibration/Metrology, Spare Parts Manager, EHS 

Innovation

  • Lead and optomize planning process through the use of digtial technologies

Complexity

  • Must have proven track record of planning/scheduling work in a complex and dynamic environment

What you bring to Takeda:

  • A recognized and applicable third level engineering qualification to Diploma level or higher or trade certification in combination with appropriate relevant experience
  • Minimum of 5 years' experience in a pharmaceutical/medical device or other similar highly regulated industry
  • Previous proven experience working in Engineering, Maintenance or Manufacturing function
  • Ability to estimate labor hours, materials and visualize job execution
  • Must have experience of planning/scheduling of work in SAP
  • Ability to understand what constitutes good work instructions
  • Able to read blueprints and technical drawings
  • Understanding of the proper use of work orders, priorities, scheduling, etc.
  • Orientation and commitment to customer service
  • Ability to recognize job hazards and apply the right safety measures such as hot work permits, lock-out-tag-out (LOTO) and personal protective equipment
  • Understanding of Good Manufacturing Practices (GMP)

Additional information

What Takeda can offer you:

  • Full Healthcare Cover - includes dependents
  • Pension Scheme
  • Attractive Bonus
  • Subsidised canteen
  • Parking facilities with electric car charging points
  • Health & Wellness programs including onsite flu shots and health screenings
  • Educational Assistance

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.

Senior Process Engineer

Location: Lessines, Belgium

About the role:
An exciting opportunity for an Engineer to join our dynamic team as Senior Process Engineer is open within our factory of the future in Lessines.

As a senior professional, you will be involved in projects related todesign, installation modification, commissioning and qualification of systems according to EHS, GMP and GEP requirements. You will be acting as one of the main actor within the team that will propose improvements to the processes and to equipment to minimize production downtime and increase quality.

We also count on your support with the day-to-day requests from maintenance and production while being a proactive participant in our daily operational meetings.

How you will contribute: 

  • You must be able to manage modifications without assistance or be integrated in larger projects teams. In particular, the position implies:
  • You will execute the basic Design and provide your support for project spending forecast, as well as detailed design of new or modified systems.
  • Writing and execution of validation packages.
  • You will be providing training to users impacted by changes and new equipment, as well as coordinating up to 3 engineers as participants on a single project.
  • Manage that the technical documentation under your responsibility is up to date and available for each employee of TAKEDA Lessines.
  • Occasionally, you will be writing Tenders.

We also expect you to:

  • Be on the floor to understand ,analyze problems and recommend efficient improvement to minimize production down time and increase quality.
  • To support site activities as a technical professional to facilitate process deviations.
  • Perform troubleshooting support of maintenance and production
  • Provide knowledge support to contractors for equipment issues.

What you bring to Takeda:

  • Master degree in Mechanics, Electrical, Process Engineering or Pharmaceutical Engineering (or Bachelor's degree with relevant experience)
  • You have alreadyexperience in engineering in the pharma industry/GMP environment.
  • You are comfortable with the technological evolution for electrical and mechanical systems.
  • Good communication skills and the ability to lead and perform effectively in multi-disciplinary teams
  • You have the ability to prioritize multiple tasks and work on multiple projects simultaneously
  • You are experienced with Quality Systems and Processes in a GMP regulated and FDA licensed manufacturing site.
  • Experienced with Purification or clean piping processes
  • You have good experience in project management, preparing project budgets and timelines.
  • Must be sensitive to Data Integrity aspects
  • You are Fluent in FrenchB2 level in English
  • You are enthusiastic to join our amazing team in Lessines and you are sharing out Takeda’s Values!

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 or other status. At Takeda, we embrace diversity as a whole.

Computer System Validation(CSV) Engineer

Location: Lessines, Belgium

About the role:

  • The CSV Validation Engineer is responsible to perform Computerized System Validation activities according to applicable regulatory requirements.
  • As Validation Engineer you will be responsible for planning, execution and reporting of computerized validation tasks within the Engineering Services department.
  • The role responsibility covers the definition of validation strategy, creating, executing, and enhancing CSV validation activities for the site.

How you will contribute:

  • You will ensure qualification/validation activities are performed linked to his/her part of the business (Purification, Finishing, Packing or CSV), including the preparation of validation documentation and protocols
  • You will act as a technical validation expert, prepares, implements and coordinates the validation documentation required to assure the proper development of a project and support regulatory submissions.
  • You will prepare/lead the Periodic Review for Critical Systems.
  • As Validation Expert, you will provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.
  • You will also manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
  • Your support will be needed in guiding our contractors or junior peers as well as provide day to day guidance for the execution of validation activities.
  • Defend validation topics related to your projects during Regulatory Inspection and prepare validation parts of the submission file
  • You may be assigned with some additional tasks based on your experience and willingness to extend your expertise and growth within our organization.

What you bring to Takeda:

  • Master’s degree in engineering (industrial, automation), or other job related disciplines.
  • You have at least 2 years' experience as a Validation Engineer with efficient technical skills.
  • You have an excellent level in French and good level in English.
  • Your knowledge of the pharmaceutical industry or industrial IT or Automation. You are familiar with Quality Management and GxP Regulations
  • Knowledgeable in Quality Systems, cGMP, GDP, GAMP5 methodology and data integrity requirements.
  • You are good communicator.
  • Because you will work in a dynamic environment, you manage to prioritize multiple tasks and work on multiple projects simultaneously.
  • Knowledge of the manufacturing processes and production automated
  • Your work usually requires excellent analytical skills with systematic approaches to problem solving.

If you think that you don't have all the above mentioned competencies, well maybe you are underestimating yourself - don't hesitate to apply!

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 or other status. At Takeda, we embrace diversity as a whole.

Senior Validation Engineer (major strategic project)

Location: Lessines, Belgium

About the role:

  • We are looking forward to welcoming our new colleague that will join us as a Senior Validation Engineer.
  • Among your main responsibilities, you will be in charge to ensure that the qualification/validation activities that are assigned to your department are performed accurately.
  • You will be specifically responsible for an entire discipline/scope on a major strategic project for the site (New manufacturing building).
  • You will contribute to continuous improvement on major topics, standardization, and simplification of processes.
  • As a Senior member of our team, you will be supporting the Validation Leader as an experienced validation expert and potential delegate.

How you will contribute:

  • Will prepare and implement the validation testing and documentation required to assure the proper development of projects, within the scope Packing, Logistics and Power plant. You will be specifically responsible for an entire discipline/scope on a major strategic project for the site (New manufacturing building).
  • Will provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of the safe, reliable, and consistent operation of the system.
  • Will defend validation topics related to your projects during Regulatory Inspection and prepare validation parts of the submission file.
  • Will support contractors or junior engineers as well as provide day to day guidance for the execution of Validation activities.
  • Will contribute to continuous improvement on major topics and International standardization for topics related to his/her part of the business, with the support of our Validation leader if needed.

What you bring to Takeda:

  • You are bringing a minimum of 3 years as a Validation Engineer with efficient technical skills. You may also have strong experience in utilities within the pharmaceutical environment.
  • You hold a BS Degree in Engineering , Chemistry of other Life Sciences / or strong experience as a Validation/Utilities Engineer.
  • As part of your function, you are naturally familiarized with the GMP environment, the Validation methodologies, and with the Quality Systems cGMP.
  • Your communication skills will be highly appreciated, and you speak greatly French, and English at a very good level.
  • Your understanding of technical installations is excellent and you are comfortable with technical and quality documentation, engineering aspects, and protocols to support all relevant activities on site.
  • You have already experienced the management of complex situations within your work environment and have knowledge of how to manage them.
  • You have a strong analytical mindset; you are able to find solutions for optimization and standardization.
  • You are a very autonomous individual with a strong sense of organization.
  • As a senior member of our Team, you are enjoying the innovation and you are one of the first that bring new ideas and sustainable proposals.
  • You are enthusiastic to join one of the most amazing Teams of Takeda at our Factory of the future in Lessines.

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 or other status. At Takeda, we embrace diversity as a whole.

Quality Validation Engineer

Location: Lessines, Belgium

About the role:

  • You are part of the Quality Validation department and also part of a dynamic team working on strategic projects of Takeda Lessines.
  • As Quality Validation Engineer, you perfom the quality oversight of the qualification, validation and revalidation activities related to product, process, cleaning, equipment, material, shipping, IT and computerized systems.

How you will contribute:

  • Ensure quality oversight and active quality support for validation and revalidation activities for the site.
  • Provide quality guidance for the development of the strategy and risk analysis related to the validation activities.
  • Review and approve validation documentation (RA, DQ, IQ, OQ, PQ, PPQ) and associated specification documents (URS, Functional/ Design Specification).
  • Review periodic evaluations in order to maintain the accurate
    validation state of processes, facilities and systems, by ensuring compliance to procedures and regulatory requirements.
  • Provide support, expertise and guidance in interpreting standards, SOPs, guidance’s, policies, regulatory regulations, and internal
    regulations to assure compliance.

What you bring to Takeda:

  • Master degree with at least 3 years of experience in Validation and/or Quality Assurance/systems within the pharmaceutical industry, or equivalent.
  • Good understanding of pharmaceutical quality management systems and regulations including current GMPs & GDDPs.
  • Experience in Computerized Systems Validation (CSV) would be a plus.
  • Good level in written and spoken French and English.
  • Critical thinking mindset, analytical approach, able to deal with ambiguity and problem solving skills.
  • Demonstrated ability to work autonomously .
  • Ability to develop and maintain good working relationships with customer groups and support a positive environment of teamwork and collaboration.
  • Good organizational skills.
  • Assertiveness
  • Flexibility

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 or other status. At Takeda, we embrace diversity as a whole.