Associate Validation EngineerSterigenics U.S., LLC in • Los Angeles, CA, US
Associate Validation Engineer
Sterigenics U.S., LLC in • Los Angeles, CA, US
Hace 1 día
Tipo de contrato
- A tiempo completo
Descripción del trabajoCycle 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. Does not supervise the work of others. 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. ISO 9000 experience a plus. Excellent written and verbal communication skills. Strong computer skills. Forklift driving experience preferred, however internal training will be given. 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. 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)
Associate Validation Engineer (Finance)
Reporting to the Quality Assurance (QA) Manager or equivalent manager / supervisor, Associate Validation Engineer will provide management with information and data on all key aspects of each customer's validation project, which is used by both the plant and the customer to determine the course of routine processing. Must effectively interface with Sales, Operations, Corporate EO Technology, Laboratory (if any), EHS, Quality, Engineering and other Sterigenics facilities, as well as customers and regulatory personnel.
Duties and 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.
Supervision Given
Education, Experience, & Skill Required
Special Requirements
Training Required
Payrate
75,500 and 123,000 per year; depending on experience.
Benefits
Sotera Health offers a competitive benefits package that includes :
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.
VEVRAA Federal Contractor
J-18808-Ljbffr
Crear una alerta de empleo para esta búsqueda
Validation Engineer • Los Angeles, CA, US
Ofertas relacionadas
Sensory & Product Development Technician.Full-time, Long-Term Temporary.Monday–Friday, 9 : 00 AM – 6 : 00 PM.A well-established consumer goods company is seeking a motivated and detail-oriented Sensory...Mostrar más
City of Industry, CA, 91744, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's ability to lawfu...Mostrar más
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all appl...Mostrar más
A company is looking for a CDI-DRG Validation Auditor to perform documentation and coding reviews in a remote contract position.
Key Responsibilities Review hospital records to validate the accura...Mostrar más Junior Associate Buyer – Aerospace & Defense (6-Month Contract).AM – 7 : 00 PM or 12 : 00 PM – 9 : 00 PM.We are working with a client in the.
This opportunity will be a 6-month contract opportunity locate...Mostrar más 
US-CA-San Francisco and Silicon Valley | US-MA-Boston | BE-Brussels | US-IL-Chicago | UK-London | US-CA-Los Angeles | US-NY-New York | US-DC-Washington.
Cornerstone Research provides economic and fi...Mostrar más
Associate Interpretation Specialist.Commensurate with experience and internal equity.Museum - 0854-Interpretive Content.Getty is committed to creating a welcoming workplace that reflects the variou...Mostrar más A company is looking for a Senior Design Verification Engineer.Key Responsibilities Apply verification techniques and methodologies to verify designs independently Develop test plans, including ...Mostrar más 
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all appl...Mostrar más
Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive features.The Quality Validation Engineer is responsible for the validation documentation of equipment, processe...Mostrar más A company is looking for a Project Management Senior Associate.Key Responsibilities Own and execute change control implementation plans for product launches and variations Create and manage Cust...Mostrar más 
Great opportunity for upward growth and attainable billable hour requirement!.This Jobot Job is hosted by : Chris De Armas.
Are you a fit? Easy Apply now by clicking the "Apply Now" buttona...Mostrar más A company is looking for a Rotational Associate Program participant starting January 2026.Key Responsibilities Conduct in-depth research and analysis relevant to the team's focus area Collaborat...Mostrar más 
Conceives, plans and executes manufacturing process validations plans and studies.Adhere to the Change Control and Design Control requirements.
Create robust validation documents such as Master Vali...Mostrar más Job Title : Verification & Validation System Engineer.The Verification & Validation System Engineer will delve deeply into component and subsystem designs to develop and define verification ...Mostrar más Supplier Onboarding & Compliance Agent .Supplier Onboarding and Compliance Agent.Manage onboarding and offboarding of suppliers, ensuring compliance with company policies, FAR / DFARS requirements, a...Mostrar más Review and analyze technical documents, reports, and specifications for accuracy, clarity, and consistency.Ensure compliance with industry standards and internal guidelines.Provide feedback and rec...Mostrar más A company is looking for an Associate Advanced Delivery Architect (West).Key Responsibilities Support the delivery of Advanced Services engagements under senior guidance Execute project tasks su...Mostrar más
Sensory & Product Development Technician
Vaco by Highspring • Altadena, California, United States
A tiempo completo
Última actualización: hace más de 30 días • Oferta promocionada
Quality Engineer (Aerospace)
Howmet • City of Industry, CA, United States
A tiempo completo +1
Última actualización: hace 8 días • Oferta promocionada
Equipment Validation Engineer
PSC Biotech • Los Angeles, CA, us
A tiempo completo
Quick Apply
Última actualización: hace 11 días
CDI-DRG Validation Auditor
VirtualVocations • North Hollywood, California, United States
A tiempo completo
Última actualización: hace 24 días • Oferta promocionada
Jr Associate Buyer- Aerospace / Defense Industry
Vaco by Highspring • Altadena, California, United States
Temporal
Última actualización: hace más de 30 días • Oferta promocionada
Associate - PhD
Cornerstone Research • Los Angeles, CA, United States
A tiempo completo
Última actualización: hace más de 30 días • Oferta promocionada
Associate Interpretation Specialist
The J. Paul Getty Trust • Los Angeles, CA, United States
A tiempo completo +1
Última actualización: hace más de 30 días • Oferta promocionada
Design Verification Engineer
VirtualVocations • Norwalk, California, United States
A tiempo completo
Última actualización: hace 3 días • Oferta promocionada
Equipment Validation Engineer
PSC Biotech Corporation • Los Angeles, CA, US
A tiempo completo
Última actualización: hace 1 día • Oferta promocionada
Quality Validation Engineer
Actalent • Los Angeles, CA, US
A tiempo completo
Última actualización: hace 1 día • Oferta promocionada
Senior Associate Project Manager
VirtualVocations • Whittier, California, United States
A tiempo completo
Última actualización: hace 2 días • Oferta promocionada
Construction Litigation Associate
Jobot • Orange, CA, US
A tiempo completo
Última actualización: hace más de 30 días • Oferta promocionada
Rotational Associate Program
VirtualVocations • North Hollywood, California, United States
A tiempo completo
Última actualización: hace 3 días • Oferta promocionada
Validation Engineer
TechDigital Group • Los Angeles, CA, US
A tiempo completo
Última actualización: hace 1 día • Oferta promocionada
Verification & Validation System Engineer
Actalent • Los Angeles, CA, US
A tiempo completo
Última actualización: hace 1 día • Oferta promocionada
Supplier Onboarder
Vaco by Highspring • Altadena, California, United States
Temporal
Última actualización: hace más de 30 días • Oferta promocionada
Technical Reviewer
Vaco by Highspring • Altadena, California, United States
Indefinido
Última actualización: hace más de 30 días • Oferta promocionada
Associate Advanced Delivery Architect
VirtualVocations • Huntington Beach, California, United States
A tiempo completo
Última actualización: hace 1 día • Oferta promocionada