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Job Description

About the role:

Join Takeda as a Senior Validation Engineer where you will support site projects, technical transfers, and ongoing validation maintenance. You will focus on the design, authorship, and execution of commissioning, qualification and validation studies for the following major disciplines and report to the Engineering Validation Manager at our location in Social Circle, GA.

• Facilities, Utilities, and Equipment (FUE) qualification
• Units operations automation qualification with Honeywell, Delta V, and PCL-based systems
• Computerized systems validation
• Cleaning validation
• Sterilization validation
• Materials validation
• Process validation

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

How you will contribute:

• Independently designs, authors, executes and summarizes commissioning, qualification and validation studies. Partner with SMEs to ensure efficient execution of testing strategies.
• Collaboratively conduct risk and impact assessments.
• Support development of standard operating procedures (SOP) and validation assessments.
• Communicate with customers on technical issues, project timelines and validation support.
• Participate on teams to determine the root-cause and corrective actions for problems associated with investigations.
• Calculation and interpretation of data for commissioning, qualification and validation studies.
• Participate in audits and regulatory agency inspections as a representative of the Engineering Validation team.
• Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
• Support operations and communications with Program Managers.
• Exercise judgment within defined policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.
• Demonstrate continuous improvement concerning increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, and technical understanding capability.
• Lead several small projects with complex features.
• Serve on Tier 1 process teams.

What You Bring to Takeda:

• Bachelor's degree in Engineering discipline required. Minimum 7 years validation experience for non-manager role; 5+ years experience for Supervisor.
• 7 years of relevant experience in a GMP regulated environment.
• At least 4 years of commissioning, qualification and validation (CQV).
• Validation and system experience in the following applicable areas:
• Sterilization and aseptic processing validation is essential.
• Cleaning validation of manufacturing equipment.
• Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
• Protein purification from mammalian plasma and blood.
• Technical experience with automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
• Lead validation projects, coordinate contractors, and achieve results.
• Direct manufacturing operations experience and biotechnology processes
• Must work in a team environment, working with individuals at all levels in an organization and departmental areas.
• Knowledge of Industry guidelines (ISPE, PDA), US and international r