Job Description
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.
About Us
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
ICU Medical EEO Policy Statement
OFCCP Equal Opportunity Posters
“Know Your Rights” Poster
Pay Transparency Nondiscrimination Provision
ICU Medical CCPA Notice to Job Applicants
