Validation Engineer II

ICU Medical•Austin, TX

17d

About The Position

The Validation Engineer II is responsible for process knowledge and validation activities for an assigned area, which may include equipment, automated process control systems and computerized systems, processes and cleaning, terminal sterilization, or facilities and utilities. The role applies validation theory and technical knowledge to prepare and execute validation deliverables, support company goals, and develop validation procedures. It may include supervising reporting technicians and acting as a delegate for the Senior Validation Engineer when they are absent. The engineer develops validation strategies and plans aligned with company policies, procedures, and external regulatory guidance; writes, executes, reviews, and approves validation documents; and plans revalidation of plant equipment, facilities, utilities, processes, control systems, software, and cleaning. The role also tracks and reports assigned project activities, assesses risks and changes, investigates failures and adverse trends, determines root causes, and completes corrective and preventive actions. The engineer provides technical direction and training, mentors technicians, collaborates with plant and corporate groups, and communicates project timelines. Additional travel may be required for facility acceptance testing of new equipment or technical transfer of new processes.

Requirements

Bachelor’s degree in Engineering or Science; Engineering is preferred. Candidates with other technical bachelor’s degrees will be considered with at least two years of direct validation experience.
At least two years of 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.
High resourcefulness, including the ability to remove obstacles, resolve problems, make decisions with incomplete information, and accomplish goals through innovative planning.
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 lbs unassisted.

Nice To Haves

Engineering degree.
Working knowledge of statistics.
Direct validation experience.
Experience interacting with regulatory and third-party representatives.
Prior supervisory experience.

Responsibilities

Develop validation plans and strategies aligned with validation policies, procedures, and external regulatory requirements and guidance.
Develop and maintain an annual plan for periodic reviews, requalifications, and continued process verifications, and report progress as required.
Write and execute validation documents, including IQ, OQ, IOQ, PQ, PV, PR, and CPV documents, in compliance with plant policies and procedures.
Identify risks and issues proactively and complete risk assessments as needed.
Initiate and author validation assessments and validation gap analyses as required.
Plan and lead revalidation of existing plant equipment, facilities, utilities, processes, control systems, software, and cleaning, including sterilization equipment.
Review and approve validation documentation, mentoring Validation Technicians as applicable.
Ensure validation packages contain relevant information, rationales, references, and data, and that reports and protocols are reviewed and approved as appropriate.
Plan, track, and report assigned validation projects or activities.
Own investigations into failures or adverse trends, identify root causes, and determine and complete corrective and preventive actions.
Seek subject matter experts and apply validation expertise, analytical skills, and systematic problem-solving.
Supervise and mentor validation technicians and supervise validation consultants, providing project and technical direction as needed.
Work with supervision from the Senior Validation Engineer or Manager as needed.
Act as Change Control Owner for projects as required; assess change controls and perform impact assessments based on process knowledge and validation principles and policies.
Provide technical validation training to plant personnel.
Write or assist with writing 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 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 transfer of new processes.
Perform other related duties as assigned or required.