Process Validation Engineer

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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)

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