Process Validation Engineer
Singapore, SingaporeVaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is applying innovation to tackle some of the world's most challenging infectious diseases, such as dengue, COVID-19, Zika and norovirus. Takeda’s team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world's most pressing public health needs.
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Job Description
About the role:
The individual will be expected to provide process validation support for Takeda vaccines manufacturing operations located in internal and CMO manufacturing locations. The process validation activities related to the vaccine manufacturing sites include, but are not limited to, the following areas:
Oversight of Process Validation activities including development, facilitation and support of strategies of process validation and related activities/documentation for Drug Substance, Drug Product and Diluent manufacturing processes for Lifecycle Validation Stages.
Authoring of process validation studies, as well as ensuring compilation of data and results into summary and final reports.
Align manufacturing processes with executed validation
Participate in regulatory inspections.
Identify opportunities for continuous improvements, participate in the deployment of best practices, represent global validation for Vaccine Business Unit at project meetings and support/maintain the process validation in various internal and external communication, meetings, etc.
How you will contribute:
1. Oversight including developing, and authoring strategy and/or execution documents for Process Validation activities in the following areas:
Tech transfer (new product introduction)
Change management
Continuous lifecycle management
2. Develop and assess the following Quality System elements for Process Validation:
CAPAs
Deviations
3. Participate and contribute in design, development, validation, and routine GMP activities:
Provide technical input to validation activities
Represent process validation during tech transfer activities as required.
Represent process validation during site GMP activities and participate on cross-functional teams
Support process validation Quality Systems
4. Identify opportunities for personal and professional development, continuous improvements, participate in the deployment of best practices, represent MS&T Validation at various project and commercial meetings and support/maintain the process validation communications board.
5. Participate in regulatory activities including inspections and filing for Process Validation.
6. Train other executing staff on validation protocols as applicable.
What you bring to Takeda:
Essential:
Bachelor's in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field with a minimum of 5 years relevant experience. Master’s in related field with a minimum of 3 years relevant experience. PhD. In related field with minimum of 0 years relevant experience.
Previous experience developing validation strategies and implementing for projects. Knowledge of the Lifecycle Validation stages and further implementation. Understanding of cGMP requirements for validation documentation. Understanding of drug substance, drug product manufacturing. Excellent written and verbal communication skills and demonstrated ability to collaborate with multiple functions to execute validation activities and incorporate validation results into routine operational practices.
Desired:
Working knowledge of risk assessment methodologies and practices including prior experience using established risk analyses for testing strategy development and justification. Experience authoring & executing process validation studies for commercial GMP manufacturing processes including process qualification (PPQ) and PPQ supporting studies. Familiarity with broad range of QC analytical test methods and analytical method development and capabilities.
Key Skills, Abilities, and Competencies
Qualified candidates will have:
Relevant experience with industry process validation requirements and expectations
Working knowledge of the science and technology for the major unit operations associated with manufacturing operations.
Experience with troubleshooting / problem solving and risk assessment / mitigation.
Excellent written and verbal communication skills.
Strong team member with demonstrated ability to work collaboratively with others.
Ability to work independently in a fast paced environment and manage multiple projects and priorities.
Complexity and Problem Solving
The candidate will:
Exercise judgment within defined procedures and practices to determine appropriate action.
Must have the ability to efficiently organize and analyze data, quantify risks, and identify gaps under supervision.
Must have the ability to propose solutions to problems and escalate issues with proposed solutions to management as necessary.
Internal and External Contacts
The person in this role will be instrumental in working with other members of the Quality Assurance, Manufacturing, and Technical Operation organizations to develop and execute process validation studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals.
Other departments this person will work closely with include: Process Development, Engineering, Regulatory Affairs, Quality Control and Facilities.
Other Job Requirements
Must be able to perform necessary gowning activities required for GMP facility access.
Travel to India manufacturing locations and other Vaccine manufacturing areas is required. (Up to 1-2 times per year)
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, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Singapore, SingaporeWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeSuccess profile
What makes a successful team member within Vaccines at Takeda?
- Integrity
- Fairness
- Inventive
- Perseverance
- Honesty
- Collaborative
Our leadership
Vaccines represent a new dimension of global impact — successful leadership at Takeda can be encompassed in these four pillars:
Demonstrating strategic enterprise thinking, finding innovative ways to serve patients and build trust, reputation and business
Creating the environment that inspires and enables people to move the organization forward
Focusing on the few priorities and delivers superior results
Elevating the capabilities of the organization for now and the future
Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through 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
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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