Process Validation Engineer
Zurich, Canton of ZurichVaccines 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
At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.
Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?
OBJECTIVES/PURPOSE
Validation subject matter expert to conceive, design and direct the execution of validation/technical shared services projects in support of VBU for Qdenga product.
Oversight of Process Validation activities including development, facilitation, and support of strategies for process validation and related activities/documentation for Drug Substance, Drug Product and Diluent manufacturing processes for Lifecycle Validation Stages including PPQ and CPV programs.
Authoring, review and approval of validation documentation for Lifecycle Process Validation. Scope includes but not limited to equipment/systems, PPQ, buffer and media, filter validation, lyophilization validation, etc.
Oversight/support of execution activities, as well as perform data analysis and compilation of data and results into summary and final reports.
Align manufacturing processes with executed validation summary
ACCOUNTABILITIES
Oversight including developing, and authoring strategy and/or execution documents for Process Validation activities in the following areas:
Tech transfer/New Product Introduction (NPI)
Change management
Continuous lifecycle management
Continued Process Verification (CPV)
Develop and assess the following Quality System elements for Process Validation:
Change control
CAPAs
Deviations
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.
Support process validation during audit, inspections for manufacturing processes
Represent process validation during site GMP/commercial activities and participate on cross-functional teams
Support process validation Quality Systems
CORE ELEMENTS RELATED TO THIS ROLE
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.
DIMENSIONS AND ASPECTS:
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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Bachelor's in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field with a minimum of 3 years relevant experience. Master’s in related field with a minimum of 0 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.
Empowering our people to shine
At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.
Diversity, Equality, and Inclusion
Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.
If you are interested in this opportunity, we look forward to receiving your application via our online tool!
Learn more at takedajobs.com
Locations
Zurich, SwitzerlandWorker 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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