Senior Process Engineer, Japan New Plasma Facility ProjectJūsō-honmachi, Ōsaka
On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
Ensure Process Equipment is “fit for purpose” for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements
Main objectives (key services)
Review Capacity Modeling developed by Engineering companies
Engineering and Equipment Design
Safety engineering design and management
Recommend future strategic preparations for the project by introducing new process technologies such as robotics and delivering agile process engineering solutions
Acting as a Process Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for process equipment.
In detail, He/she will:
Report to the Engineering Manager.
Develop and maintain process equipment concepts and engineering scope based on the approved budget and schedule.
Ensure that all process equipment meet regulatory requirements, client specifications, and industry standards, and defines the user requirements.
Collaborate with other project disciplines to ensure integrated design solutions.
Guide and coordinate with the external design company on the procurement strategy and procurement package definition related to its discipline.
Review and approve design documents and concepts.
Conduct gate keeping reviews.
Review and approve contractor submittals.
Lead commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment.
With Partners in Engineering Validation support the Qualification and Validation activities for Process Equipment.
Perform Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Utilities Operations, Maintenance, Calibration, Reliability, Automation.
Manufacturing/Production, Utilities Operations, Instrument Calibration/Metrology, Spare Parts Manager, EHS, Engineering, Reliability Engineering, Sustainability Engineer
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Engineering degree or equivalent required; for example Chemical, Biochemical, Mechanical or Industrial engineering is preferred
Minimum 5 years of relevant experience
Expert of Process Unit Operations in Pharmaceutical Manufacturing
Understanding of Good Manufacturing Practices (GMP)
Good knowledge / SME for machines/lines/systems and all of its components is preferred
Excellent verbal and written communication skills in English and Japanese
LocationsOsaka (Juso), Japan
Time TypeFull time
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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