Lead Validation Engineer – GMP Systems & Equipment

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Otsuka ICU Medical LLC is seeking a Validation Engineer II to own validation activities for equipment, automated control systems, and facilities. The role focuses on developing validation plans, executing IQ/OQ/IOQ/PQ, and leading risk assessments and revalidations as required.

The candidate will write and review validation documentation, mentor technicians, and ensure compliance with cGMP and FDA guidelines while coordinating with Quality, Engineering, Manufacturing and IT teams.

Qualifications

• Must have basic knowledge of cGMPs, FDA and pharmaceutical industry guidelines.
• Knowledge in Validation disciplines such as Manufacturing/Facilities/Utilities/Lab/Solutions/Automated controls is required.
• Strong organizational, presentation and technical writing skills.
• Ability to identify risks, perform root cause analysis and implement corrective actions.

Responsibilities

• Develop Validation Plans aligned with policies and external regulatory requirements.
• Write and execute validation documents (IQ, OQ, IOQ, PQ, PV, CPV, etc.).
• Plan and lead revalidation of equipment, facilities, utilities, processes, and controls.
• Review or mentor validation technicians and manage validation projects to completion.
• Communicate timelines and coordinate with cross-functional teams; perform risk assessments as needed.

Skills

cGMP knowledge

FDA guidelines

Validation

Documentation writing

Root cause analysis

Education

Bachelor's degree in Engineering or Science

Job description

Otsuka ICU Medical LLC is seeking a Validation Engineer II to own validation activities for equipment, automated control systems, and facilities. The role focuses on developing validation plans, executing IQ/OQ/IOQ/PQ, and leading risk assessments and revalidations as required.

The candidate will write and review validation documentation, mentor technicians, and ensure compliance with cGMP and FDA guidelines while coordinating with Quality, Engineering, Manufacturing and IT teams.