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Job Description

About the role:

As a Quality Validation Associate II, you will support site projects, technical transfers, and ongoing validation maintenance. You will be responsible for compliance during the review of the design, authorship, and execution of commissioning, qualification and/or validation studies for the any or more of the following major disciplines: computerized systems validation (Honeywell, DeltaV, PLC based systems, DHS), facilities, Utilities, and Equipment (FUE) qualification, electronic Batch Management (EBM), cleaning validation, QC Laboratory, or data Integrity Assessment.

How you will contribute:

• You will be responsible to maintain validation documentation aligned with Good Documentation Practices (GDP) and ensure compliance with industry standards (e.g. FDA, EU GMP, ISO, etc)

• Provides technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs. Individual must work on moderate to complex assignments, where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.

• Independently review commissioning, qualification and/or validation studies.

• Partners with SMEs to ensure smooth and efficient execution of testing strategies.

• Provides compliance guidance to engineering for all related commissioning, qualification and validation activities.

• Collaboratively conducts risk and impact assessments.

• Supports development and review of standard operating procedures (SOP) and validation assessments.

• Interfaces with customers on technical issues, project timeline, and validation support.

• Actively participates on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.

• Calculation and interpretation of data for commissioning, qualification and/or validation studies.

• Participates in audits and regulatory agency inspections as a representative of the Quality Validation team, as required.

• Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.

• Provides support for operations and communicates with Program Managers.

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.

• Demonstrates continuous improvement with respect to increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, as well as technical understanding/problem solving capability.

• Leads several small projects with complex features.

What you bring to Takeda:

• Requires bachelor's degree in science, engineering or other related technical field. 5+ years of related experience.

• A minimum of 5 years of relevant experience in a GMP regulated environment.

• At least 4 years of commissioning, qualification and validation (CQV) desired.

• Validation and/or system experience in the following applicable areas:

• Cleaning validation of manufacturing equipment.

• Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.

• Strong knowledge and experience of automation platfo