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About the Role

The Validation Engineer II is responsible for process knowledge of the validation section assigned to equipment, automated process control systems/computerized systems, process & cleaning, terminal sterilization, and facilities & utilities. The primary functions include writing validation documents, executing validation documents, and developing validation procedures.

Responsibilities

Develop Validation Plans, ensuring strategies align with validation policies, procedures, and external regulatory requirements.
Develop and maintain an annual plan including periodic reviews, re-qualifications, and continued process verifications.
Report on validation progress as required.
Write and execute validation documents (IQ, OQ, IOQ, PQ, PV, PR, CPV, etc.) compliant with plant policies and procedures.
Proactively identify risks/issues and complete risk assessments.
Initiate and author validation assessments and validation gap analysis.
Plan and lead revalidation of existing plant equipment, facilities, utilities, processes, control systems, software, and cleaning.
Review and approve validation documentation.
Mentor Validation Technicians as applicable.
Ensure validation packages contain all relevant information, rationales, references, and data to support changes or routine activities.
Ensure all reports and protocols are reviewed and approved.
Accountable for planning, tracking, and reporting for assigned validation projects or activities.
Own investigations in the event of failures or adverse trends.
Identify root cause, determine, and complete corrective/preventative actions.
Seek subject matter experts (SME) and bring validation expertise, strong analytical and systematic problem-solving skills.
Supervise and mentor validation technician(s).
Supervise validation consultant(s) to provide project and technical direction.
Work with supervision as needed and as provided by Sr. Validation Engineer or Manager.
Act as Change Control Owner for projects.
Assess change controls and perform impact assessment based on knowledge of process and validation principles and policies.
Provide technical training in validation to plant personnel.
Write or assist with the writing of Standard Operating Procedures and Validation Master Plans.
Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications, and policies.
Interact with Quality, Engineering, Manufacturing, Packaging, IT, and business area users to understand processes, equipment functionality, and use of automated control systems/computerized systems.
Communicate and manage timelines for validation projects to project manager or site management.
Perform other related duties as assigned or required.

Requirements

Must have basic knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines.
Knowledge in one of the following disciplines is required: Validation, Manufacturing, Facilities/Utilities, Laboratory, Solution processes, Terminal sterilization, Automated controls systems/software.
Must have good organizational, presentation, meeting facilitation and technical writing skills.
Working knowledge of statistics is preferred.
Requires a high level of resourcefulness, an ability to get things done by removing obstacles, perceiving, and resolving problems, making difficult decisions with less than complete information provided, and finding ways to accomplish goals through innovative planning.
Must maintain a thorough working knowledge of the ICU Medical Specification Systems.
A high level of attention to details and the ability to proofread and audit validation documents is required.
Must be able to work weekends and holidays as required to meet deadlines.
Must be at least 18 years of age.
Time split between office and manufacturing environment.
Some physical demands when working on the manufacturing floor executing validation runs.
Occasional lifting.
Must be able to lift up to 25 lbs unassisted.

Skills

Validation
Manufacturing
Facilities/Utilities
Laboratory
Solution processes
Terminal sterilization
Automated controls systems/software
cGMPs
FDA
Pharmaceutical industry guidelines
Organizational skills
Presentation skills
Meeting facilitation
Technical writing
Statistics
Resourcefulness
Problem-solving
Decision-making
Attention to detail
Proofreading
Auditing
Change Control
Risk assessment
Root cause analysis
Corrective/preventative actions

Location

Office
Manufacturing environment

Work Type

Full-time
Onsite

Experience Level

Two (2) or more years of direct validation experience (if Bachelor's is not in Engineering)
A minimum of two (2) years' experience
Prior supervisory experience is desirable but not required

Education Level

Bachelor’s Degree required: Engineering or Science (Engineering Preferred)
Other technical bachelor’s degrees will be considered if they have two (2) or more years of direct validation experience.

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.
Otsuka ICU Medical EEO Policy Statement
Know Your Rights: Workplace Discrimination is Illegal Poster
Otsuka ICU Medical CCPA Notice to Job Applicants