Position Summary
JOB DESCRIPTION
Coordinates the activities of the Engineering work order function for maintenance PM's, DM’s, and CM’s. Provides guidance to work order administration specialists to ensure proper preparation, data entry, processing, and filing of work order and equipment documentation. Responsible for the proper documentation and administration of the plant preventive maintenance program, equipment files/numbering system, and plant engineering historical files. Performs engineering audit functions and interfaces with regulatory agencies.
This position is 100% onsite at our Austin, TX manufacturing facility.
Essential Duties & Responsibilities
- Coordinate the activities of the Engineering Documentation Center for PM's, Calibrations, DM’s, and CM’s including supervising of the work order administration specialists.
- Serve as point of contact and subject matter expert in discussions or issues related to Oracle EAM.
- Adhere to standards related to version control testing and migration
- Create, track, and manage incidents impacting proper functioning of the CMMS
- Responsible for monitoring and auditing the plant equipment preventive maintenance program, equipment history files per retention schedule, and other critical plant files, as directed.
- Maintain proper storage and knowledge of the location of all PM’s, CM’s, DM’s, and history files for rapid response to internal and external audit and investigation requests
- Ensure compliance of PM information and other data to FDA regulations and cGMP's/cGDP’s by checking all incoming documentation, this includes PM records, CM records, DM records, Calibration records, Engineering Change request records, PER’s records, utility log sheets and history files.
- Store and maintain all critical utility and production equipment software and selected hardware to comply with cGMP requirements for control of critical software and retention schedule.
- Assign equipment numbers to all new or modified equipment.
- Direct the issuance of PM work orders and ensure their timely completion by monitoring work and issuing periodic overdue reports.
- Issue and store records of HVAC HEPA filter testing.
- Maintain files of critical communications with federal, state, and local regulatory agencies relative to all plant equipment and systems.
- Maintain an intimate knowledge of all PM, DM, CM, filter, equipment number systems, such that retrieval for regulatory audits is done in a timely and efficient manner.
- Adhere to cGMP and cGDP guidelines, recommend updates to SOP's and plant policies/rules to maintain compliance where appropriate.
- Function as the Subject Matter Expert (SME) for engineering documents, providing guidance for compliance and consistency when there is not total agreement of the requirements by users.
- Perform other related duties as assigned or required.
Knowledge & Skills
- Must be extremely organized and able to multi-task to provide specific details of all documentation center files and retrieve files.
- Must be able to work with managers and supervisors in many different situations and work effectively to resolve issues.
- Must possess excellent interpersonal skills to be able to deal with all levels of personnel, both internal and external, at other company locations and regulatory agencies. Site SME for Maintenance Management System software and have the ability to perform queries and reports.
- Must have advanced skills in Excel
- Must pass GMP and area certifications and trainings.
- Part 11 cGMP experience a plus
Minimum Qualifications, Education & Experience
- High school diploma or equivalent. AA in electronics/mechanical preferred
- Minimum three years’ experience with maintenance documentation experience.
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
