FLSA Status - Exempt
Position Summary
The Validation Engineer I is responsible for process knowledge of the validation section assigned to:
- Equipment
- Facilities & Utilities
- Process & Cleaning
- Terminal sterilization
The primary functions of the Validation Engineer I include the following:
- Possess process knowledge to design validation documents
- Knowledge of validation theory and content of validation deliverables/activities
- For Process and Cleaning: Technical Transfers of products
- Execution of validation documents to support company goals
- Development of validation procedures
Essential Duties & Responsibilities
- Develop Validation Plans, ensuring strategies are in alignment with validation policies, procedures and external regulatory requirements and guidance. As appropriate develop and maintain an annual plan to include periodic reviews, re-qualifications and continued process verifications to be completed during each calendar year. Reporting on progress as required.
- Write and execute validation documents (IQ, OQ, IOQ, PQ, PV, PR, CPV, etc.) compliant with plant policies and procedures. Proactively identifying risks/issues and completing risk assessments as necessary.
- Initiate and author validation assessments and validation gap analysis as required.
- Plan and lead revalidation of existing plant equipment (including sterilization equipment), facilities, utilities, processes, control systems, software, cleaning, etc.
- Review and approve validation documentation.
- Ensure validation packages contain all relevant information, rationales, references, and data to support the change or routine activities and that all reports and protocols are reviewed and approved as appropriate.
- Accountable for planning, tracking and reporting for assigned validation projects or activities.
- Supervise validation consultant(s) to provide project and technical direction, as needed.
- Act as Change Control Owner for projects as required.
- Assess change controls; perform impact assessment based on knowledge of process and validation principles and policies.
- Work with QA and more senior validations colleagues to defend completed validations to regulatory and third-party representatives during inspections and audits as required.
- Provides 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 as needed 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
- Additional travel may be required for Factory Acceptance Testing (FAT) of new equipment or technical transfer of new processes.
- Work on special projects as they arise
Knowledge & Skills
- Must have knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines. Knowledge in one of the following disciplines is preferred:
- Validation
- Manufacturing
- Facilities/Utilities
- Laboratory
- Process & Cleaning
- Terminal sterilization
- 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.
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor’s degree is required: Engineering or Science (Engineering Preferred).
- Candidates with other degrees will be considered if they have one (1) or more years of direct validation experience.
- Minimum of one (1) year experience preferred in validation or a pharmaceutical GMP environment.
- Experience interacting with regulatory and third-party representatives preferred
Work Environment
- Time split between a professional office environment which routinely uses standard office equipment and a clean room manufacturing environment.
- Some physical demands when working on the manufacturing floor executing validation runs.
- Must be able to occasionally move and lift objects of up to 25 lbs
- While performing the duties of this job, the employee may be required to sit or stand for long periods of time
- Typically requires travel 5-20% of the time.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Quality & Validation
Primary Location
US-TX-Austin
Schedule
Full-time
Shift
Day Job
