Description

FLSA Status - Exempt

Position Summary

Completes advanced validation projects with peer input and guidance from engineering and validation management. A specialist on complex technical and business matters. Work is highly independent. May assume a team lead role for the work group. May also lead validation contract support and be responsible for tracking validation hours and budget.

Essential Duties & Responsibilities

• Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions. Plans, organizes and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements.

• Receives general project direction. Responsible for project progress.

• Prepares, reviews, and executes computerized system validation protocols per local procedures and Food and Drug Administration (FDA) regulations.

• Decisions consistently affect multiple or critical projects in the business and may impact external relationships.

• Serve as project coordinator or project manager for validation/qualification aspects of projects.

• 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

• Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager.

• Work on special projects as they arise

• Support inspection readiness, participate in regulatory agency inspections and provide audit support, as required.

• Lead continuous improvement activities for the validation program and revise, create and approve validation documents and procedures

• Develop technical assessments using engineering principals and standards to support leveraging existing validation studies for changes that do not represent a new worst case.

Knowledge, Skills & Qualifications

• Has an advanced understanding of validation and regulatory requirements

• Can assess what work supports the validation strategy and make insightful recommendations regarding priorities

• Expert in equipment, utilities and facilities domains of validation. Familiar in other areas of domain expertise within the team.

• Experience using project management tools is a plus.

Education and Experience

• Must be at least 18 years of age

• Bachelor's degree from an accredited college or university

• 7+ years of validation, science/technical or engineering background required, pharmaceutical validation or engineering experience preferred.

Physical Requirements and Work Environment

• This is largely a sedentary role.

• This job operates in a professional office environment and routinely uses standard office equipment.

• Work may be performed in a clean room environment

• Must be able to occasionally move and lift objects of up to 25 lbs

• 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.