Validation Engineer II

Otsuka ICU Medical•Austin, TX

About The Position

The Validation Engineer II is responsible for process knowledge and validation activities in an assigned area, which may include equipment; automated process control and computerized systems; process and cleaning; terminal sterilization; or facilities and utilities. The role requires knowledge of validation theory and deliverables, including relevant technologies such as PLCs, controls, robotics, barcode readers, vision systems, autoclaves, sterilizers, and ovens, as well as technical transfers of products. The engineer writes and executes validation documents, develops procedures, supervises reporting technicians, and serves as delegate for the Senior Validation Engineer when that person is absent. The position develops and executes validation strategies and plans aligned with company policies, procedures, and regulatory requirements. It leads revalidation and validation projects, reviews and approves documentation, tracks and reports project progress, investigates failures and adverse trends, and determines corrective and preventive actions. The engineer also mentors and supervises validation technicians and consultants, supports change control, trains plant personnel, and works with cross-functional groups to understand processes, equipment, and automated or computerized systems. Additional travel may be required for equipment acceptance testing or process technical transfers; typical travel is less than 5%.

Requirements

Bachelor’s degree in Engineering or Science; Engineering is preferred.
A minimum of two years of experience is required.
Candidates with other technical bachelor’s degrees will be considered if they have two or more years of direct validation experience.
Basic knowledge and understanding of cGMPs, FDA requirements, and pharmaceutical industry guidelines.
Knowledge in at least one of the following disciplines: validation, manufacturing, facilities/utilities, laboratory, solution processes, terminal sterilization, or automated control systems/software.
Good organizational, presentation, meeting facilitation, and technical writing skills.
Ability to maintain thorough working knowledge of ICU Medical Specification Systems.
Strong attention to detail and ability to proofread and audit validation documents.
Ability to work weekends and holidays as required to meet deadlines.
Must be at least 18 years of age.
Ability to lift up to 25 pounds unassisted.

Nice To Haves

Engineering degree preferred.
Direct validation experience preferred.
Working knowledge of statistics preferred.
Experience interacting with regulatory and third-party representatives preferred.
Prior supervisory experience desirable but not required.

Responsibilities

Develop validation plans aligned with validation policies, procedures, regulatory requirements, and guidance; maintain annual plans for periodic reviews, re-qualifications, and continued process verification, and report progress.
Write and execute validation documents, including IQ, OQ, IOQ, PQ, PV, PR, and CPV documents, identifying risks and completing risk assessments as needed.
Initiate and author validation assessments and gap analyses as required.
Plan and lead revalidation of plant equipment, sterilization equipment, facilities, utilities, processes, control systems, software, and cleaning activities.
Review and approve validation documentation, mentoring Validation Technicians as applicable.
Ensure validation packages contain supporting information, rationales, references, and data, and that reports and protocols are appropriately reviewed and approved.
Plan, track, and report assigned validation projects and activities.
Lead investigations of failures or adverse trends, identify root causes, and determine and complete corrective and preventive actions, seeking subject matter experts as needed.
Supervise and mentor validation technicians and provide project and technical direction to validation consultants as needed.
Work with supervision provided by the Senior Validation Engineer or Manager as needed.
Act as Change Control Owner for projects as required and assess change controls for process and validation impacts.
Provide validation technical training to plant personnel.
Write or assist with Standard Operating Procedures and Validation Master Plans.
Review and provide feedback on new and revised validation guidelines, specifications, and policies.
Work with Quality, Engineering, Manufacturing, Packaging, IT, and business-area users to understand processes, equipment functionality, and automated or computerized systems.
Communicate and manage validation project timelines with project managers or site management.
Travel as needed for Facility Acceptance Testing of new equipment or technical transfers of new processes.
Perform other related duties as assigned or required.