FLSA Status - Exempt



Position Summary

Completes validation activities of writing and executing protocols, performing qualification and validation status assessments with guidance from more experienced engineers and managers. Gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work and is generally independent and collaborative in nature. Completes intermediate to advanced projects with minimal guidance from more experienced engineers and managers


Essential Duties & Responsibilities

•Provide guidance and execute validation activities for manufacturing equipment, utilities, and facilities validation to support the validation and tech-transfer projects.
•Write validation plans, protocols, and reports for specific projects
•Conduct validation risk assessments related to specific projects, facilities, and products.
•Work independently to collect, organize, and evaluate validation data and keep validation management informed of progress and any obstacles.
•Works on problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
•Largely self-directed after work is assigned. May solicit input from senior level engineers.
•Uses creative approaches in solving complex problems.
•Integrates subsystems and components in total systems design.
•Develops specifications from customer requirements.
•May supervise others during project-specific activities. Trains new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May provide input on performance evaluations to area manager.
•Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
•Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus.
•Work on special projects as they arise.



Knowledge & Skills

•Has solid understanding of validation and regulatory requirements.
•Have a solid understanding of the validation strategy and can recommend solutions to critical issues.
•Requires the ability to make significant decisions directly impacting the success of one or more projects, or adjacent workgroups/functions.
•Advanced tech-transfer, process and cleaning validation knowledge. Familiar in other areas of domain expertise within the team.


Minimum Qualifications, Education & Experience
•Must be at least 18 years of age
•Bachelor's degree from an accredited college or university is required
•4-7 years of validation, science/technical or engineering background required, pharmaceutical validation or engineering experience preferred.
•Alternatively, a master's degree and 2 years of experience will also be considered.


Work Environment

•This is largely a sedentary role.
•This job operates in a professional office environment and routinely uses standard office equipment.
•Work is performed in a clean room environment
•Must be able to occasionally move and lift objects of up to 25 pounds
•Typically requires travel less than 5% 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.