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About the Role
Completes advanced validation projects with peer input and guidance from engineering and validation management. Acts as a specialist on complex technical and business matters, working independently. May assume a team lead role and manage validation contract support, including tracking hours and budget.
Responsibilities
- Analyzes, plans, organizes, and completes complex projects, developing scope and creative solutions.
- Plans, organizes, and conducts technical projects, consolidating design elements for review.
- Integrates subsystems and components into total systems design.
- Develops specifications based on customer requirements.
- Receives general project direction and is responsible for project progress.
- Prepares, reviews, and executes computerized system validation protocols per local procedures and FDA regulations.
- Serves as project coordinator or project manager for validation/qualification aspects of projects.
- Delivers tailored communications to managers, peers, and customers to promote cross-functional collaboration.
- Manages training for new and current employees on documentation, equipment use, laboratory techniques, and department procedures.
- Monitors or supervises the work of employees and provides input on performance evaluations.
- Works on special projects as they arise.
- Supports inspection readiness, participates in regulatory agency inspections, and provides audit support.
- Leads continuous improvement activities for the validation program and revises, creates, and approves validation documents and procedures.
- Develops technical assessments using engineering principles to support leveraging existing validation studies for changes.
Requirements
- Has an advanced understanding of validation and regulatory requirements.
- Can assess work that supports the validation strategy and make insightful recommendations regarding priorities.
- Expert in equipment, utilities, and facilities domains of validation.
- Familiar in other areas of domain expertise within the team.
- Experience using project management tools is a plus.
- Must be at least 18 years of age.
Skills
- Validation
- Regulatory requirements
- Project management
- Technical assessment
- Engineering principles
- Communication
- Training
- Continuous improvement
Location
- Onsite
Work Type
- Full-time
Experience Level
- 7+ years of validation, science/technical or engineering background required
- Pharmaceutical validation or engineering experience preferred
Education Level
- Bachelor’s degree from an accredited college or university
About the Company
- We manufacture the critical IV solutions providers count on to deliver consistent, reliable care.
- Each product we make helps ensure patients receive the therapies they need without disruption.
- When you work here, you become part of something bigger—a team dedicated to reliability and innovation.
- No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.
- We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.
- Join us and help shape the future of IV solutions.
Equal Opportunity
- Otsuka ICU Medical is committed to being an Equal Opportunity Employer.
- We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
- If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com.
- We are committed to providing equal access and opportunities for all candidates.