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Job Description

About the role:

The Senior Quality Validation Engineer is in the Validation Quality organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility.  You will work as part of teams providing quality oversight and approval of change control and validation deliverables to ensure that products and processes meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices.  This employee will typically focus on disciplines related to equipment, cleaning, process, control system and computer system validations. You will report to the Quality Validation Manager.

How you will contribute:

• Manage Standard Operating Procedures and other Quality System Documentation relevant to their area of expertise. Approve Standard Operating Procedures and other Quality System Documentation important to all areas of the plant.

• Develop and deliver training materials relevant to area of expertise.  Approve training materials important to all areas of the plant.

• Participate as a team member in the execution and documentation of Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages following existing procedures. 

• Review deliverables for compliance to existing requirements.  Approve validation documentation (e.g., protocols, CWRs, or risk assessments) that establishes novel requirements or assesses risk.

• Lead teams in the execution of risk management activities.

• Oversee investigations and CAPAs important to responsibilities/expertise.  Approve investigations and CAPAs important to all areas of the plant.

• Approve change controls for compliance to existing requirements.

• Lead Quality project teams and present to Plant management project plans, progress, and risks.  Represent us in areas of expertise to governmental Regulatory bodies.

• Excellent influencing/collaboration skills and teamwork mindset.

• Experience presenting to inspection auditors.

• Knowledge of descriptive statistics.  Working knowledge of inferential statistics and related techniques (e.g., sample size determination, comparison analysis, ANOVA, DoE).

• Complete assigned training on time. 

• Identify, escalate, and resolve potential compliance and safety issues.

What you bring to Takeda:

• Bachelor’s degree in science, engineering or other related technical field.

• 4+ years of related experience.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• You must not be allergic to Cephalosporin drugs.

• May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.

• May work in a cold, hot or wet environment.

• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• Will work nights, weekends, and holidays to support manufacturing whe