Reporting to the Quality Assurance (QA) Manager or equivalent manager/supervisor, the Validation Technician (VT) is responsible for assisting the QA Manager (or equivalent manager/supervisor) and Validation Engineering team in ensuring the quality/validation system requirements are met and maintained. The VT must effectively interface with Customer Service, EHS, Sales, Operations, Laboratory (if any), Quality, Engineering and other plant and corporate staff, as well as customers and regulatory personnel.
Responsibilities/Duties
Performs routine equipment calibrations (as required) and maintain history records.
Responsible for load preparation in collaboration with the validation engineer team.
Document and record process readings and constructing data packets.
Responsible for specific aspects of validation protocols and technically driven customer projects, which include but are not limited to the following:
Cycle programming and preparation of necessary process documents and safety assessments
Microbiological samples
Data collection and analysis of temperature and humidity probe data.
Assuring proper handling, storage and shipping of bioburden, LALs, biological indicators, or residual samples to the appropriate laboratory
Participates on plant safety committees and follows all established safety rules and regulations.
Executes equivalency and retrospective re-validation studies/reports.
May be required to assist with corrective action and validation process improvement activities.
May be required to execute equipment/room profiles and associated activities, including customer certificate of review.
Assists with other tasks as assigned by Supervisor and other Validation Engineering team.
Education, Experience, and Skill Required
High School Diploma or GED.
Minimum of one (1) year of experience working in a sterilization or medical manufacturing manufacturer environment with GMP/GLP knowledge preferred.
Must be able to read, write and speak fluent English (US Facilities).
Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, fractions, and decimals.
Must be able to lift a maximum of 50 pounds (23kg) and perform repetitive bending and lifting motions over a period of time.
Forklift driving experience preferred, however internal training will be given.
Computer skills desired.
Must be able to travel 10-20% to various locations as needed.
Special Requirements
Must be medically approved for respirator use (EO).
Must be able to tolerate exposure to high temperatures and high humidity (up to 130F (55C) and 65% RH for 20 minutes) (EO).
Training Required
Must complete all required training for validation internal certification.
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.
