Sterigenics · 4 months ago
Associate Validation Engineer
Salt Lake City, UT
Full-time
Onsite
Mid Level
4+ years expSterigenics is a leader in the sterilization industry, and they are seeking an Associate Validation Engineer to manage customer validation projects. The role involves planning validation activities, writing protocols, executing validation tests, and ensuring compliance with regulatory standards.
Health CareMedicalMedical DevicePharmaceuticalProduct ResearchTechnical Support
Responsibilities
Plans, organizes, and coordinates customer validation activities at the facility
Writes validation protocols and final reports supplied by the facility
Reviews and approves customer or consultant supplied validation or test protocols for execution within the limitation of the facility’s equipment and Sterigenics operating procedures and compliance with current regulatory standards
Responsible for the execution of validation protocols and technically driven customer projects, which include but are not limited to the following:
Scheduling the project runs, ancillary resources, lab testing and sample handling
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
Assures that all validation calibration activities are performed according to Sterigenics procedures and traceable to NIST
Provides support to Maintenance or Engineering in the performance of IQ/OQ/PQ activities of new or existing facility equipment
Responsible for annual equipment re-commissioning (sterilization and laboratory)
Update validation status in the relevant systems
May be required to assist with corrective action and validation process improvement activities. Performs other duties as required to support the overall plant operation and quality system
Qualification
Required
Minimum BA or BS in a science related field (or international equivalent) and/or 4-6 years equivalent experience
Two (2) to four (4) years of experience in the pharmaceutical, food or medical device industry with GMP/GLP knowledge a plus but not required
Direct experience in sterility assurance or products sterilization a plus but not required
Experience in writing and executing validation protocols preferred
Customer service and project management experience desired
Excellent written and verbal communication skills
Strong computer skills
Must be able to lift a minimum of 50 lbs. (23kg) and perform repetitive bending and lifting motions over a period of time
Must be able to work a flexible schedule including weekends, holidays (if necessary)
Must be able to travel 10-20% to various locations as needed
Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements
Knowledge and experience working with the FDA and/or international requirements for medical devices is essential
Knowledge of regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA (or international equivalent) or supplier audits
Experience in document control to satisfy all ISO 9000 and FDA (or international equivalent) Quality System 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)
Must complete all required training for validation internal certification
Preferred
Experience in writing and executing validation protocols preferred
Customer service and project management experience desired
ISO 9000 experience a plus
Forklift driving experience preferred, however internal training will be given
Benefits
Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
401(k) program with Company match that immediately vests
Paid holidays, vacation and sick time
Free financial planning assistance
Paid parental leave
Education assistance
Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
Employee Assistance Program (EAP)
Company
Sterigenics
Sterigenics, a Sotera Health company, is a global leader in comprehensive sterilization services for the medical device, pharmaceutical, food safety and advanced applications markets.
1001-5000 employees
H1B Sponsorship
Sterigenics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$307M2025-09-03Post Ipo Secondary· $307M
2020-11-20IPO
2011-03-23Acquired
Leadership Team
Kamila Sarraf
Human Resources Business Partner
Recent News
Chicago Tribune
2024-04-08
Company data provided by crunchbase