Validation Engineer II

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.

Responsibilities

• Develop Validation Plans, ensuring strategies align with validation policies, procedures, and external regulatory requirements.
• 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 as necessary.
• Initiate and author validation assessments and validation gap analysis as required.
• Plan and lead revalidation of existing plant equipment, facilities, utilities, processes, control systems, software, cleaning, etc.
• Review and approve validation documentation, mentoring Validation Technicians as applicable.
• Ensure validation packages contain all relevant information, rationales, references, and data to support changes or routine activities.
• Own investigations in the event of failures or adverse trends; identify root cause and complete corrective/preventative actions.
• Supervise and mentor validation technician(s) and provide project and technical direction to validation consultant(s).
• Act as Change Control Owner for projects, assessing change controls and performing impact assessments.
• Provide technical training in validation to plant personnel.
• Write or assist with writing Standard Operating Procedures and Validation Master Plans.
• Interact with Quality, Engineering, Manufacturing, Packaging, IT, and business area users to understand processes and equipment functionality.
• Communicate and manage timelines for validation projects to project manager or site management.
• Perform other related duties as assigned or required.

Qualifications

• Bachelor’s Degree in Engineering or Science (Engineering preferred); candidates with other technical bachelor’s degrees considered with 2+ years of direct validation experience.
• Minimum of 2 years’ experience, with direct validation experience preferred.
• Experience interacting with regulatory and third-party representatives preferred.
• Prior supervisory experience desirable but not required.

Skills

• Basic knowledge of cGMPs, FDA, and pharmaceutical industry guidelines.
• Knowledge in one of the following: Validation, Manufacturing, Facilities/Utilities, Laboratory Solution processes, Terminal sterilization, or Automated controls systems/software.
• Good organizational, presentation, meeting facilitation, and technical writing skills.
• Working knowledge of statistics preferred.
• High level of resourcefulness, problem-solving, and decision-making skills.
• Attention to detail and ability to proofread and audit validation documents.

About Us

Innovation, Impact, and Purpose. Find Your Future Here. We manufacture critical IV solutions that healthcare providers rely on for consistent, reliable care. Each product ensures patients receive necessary therapies without disruption. Join a team dedicated to reliability and innovation, where your work directly strengthens the healthcare supply chain and impacts patients nationwide. We offer growth opportunities, collaboration, and meaningful contributions in pursuit of a mission that truly matters.

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure fair consideration for all qualified applicants regardless of race, color, nationality, ethnicity, sex, gender, religion, marital status, sexual orientation, age, disability, or protected veteran status. If you need reasonable accommodation, please contact us at austinhr@icumed.com.