Process Validation Engineer

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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

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