STERILIZATION VALIDATION SERVICES MANAGER
Job Details
Management
Corporate Office/LSO - Brea, CA
Company Description

Life Science Outsourcing, Inc. 

(www.lso-inc.com) is in North Orange County in the city of Brea, California. Life Science Outsourcing, Inc (“LSO”) is a contract manufacturer of medical devices with in-built capabilities to offer clients full-service solutions through our six divisions. Clients rely on LSO to perform all activities required to introduce their products to market, from sourcing to drop shipping. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, Speed and Simplicity.

In January 2021, LSO partnered with PPC Enterprises (www.ppcenterprises.com), a leading private equity firm based out of New York, to expand LSO’s geographic reach in the medical device arena.

To help us achieve our near-term growth targets, we are currently seeking an energetic and motivated SVS Manager to join our fast-growing organization. In this role, you will provide technical expertise to Operations in sterilization and microbiological areas, while reporting to the CEO. SVS Manager will also be responsible for executive management of the Sterilization Validation Services Department. We are also invested in you, and you will have the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

And no matter where you look at LSO, you will witness our shared purpose—helping realize life’s potential—in action; it’s at the heart of what we do. Our work helps improve millions of lives. We hope you will see yourself here, too.

We encourage you to submit a resume with salary requirements.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES include the following. 

  • You will provide technical expertise to Operations in sterilization and microbiological areas.
  • Collaborate with customers to define sterilization requirements for new product development, Sustaining, and design changes.
  • Plan and perform sterilization assessments and validations for customer medical devices using Gamma, E-beam radiation and/or EO methods, compiling with ISO 11137 and ISO 11135
  • Plan and carries out cleaning, disinfection, sterilization validations for reusable devices in compliance with ISO 17664 and applicable region standards
  • Coordinate microbiological testing with approved laboratories to support project teams
  • Document Sterilization validation requirements, draft and release test protocols, reports, cleaning, disinfection and sterilization processes
  • Collaborate with Regulatory to generate Sterilization sections for product regulatory submissions and address questions from the FDA and all other Notified Bodies, on regulatory submissions and audits
  • Reviews sterilization costs and product quality and modifies sterilization services to maintain and enhance profitable operation of the company.
  • Approves all Quotes, Purchase Orders, Sales Orders, Shop Travelers, and Reports for all sterilization runs prior to implementation or issuing to customer.
  • Other duties may be assigned.

SUPERVISORY RESPONSIBILITIES

  • Manages and directs delegated activities for Sterilization Services department.
  • Serves as a delegated liaison / team member with QA, Regulatory Affairs, Research and Development and Manufacturing departments.
  • Responsibilities include directing work and appraising performance, addressing complaints, and resolving problems.

 

QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Bachelors’ degree in a technical field such as Microbiology, Biomedical Engineering, Bio Engineering, Material Science Engineering, Chemical Engineering, Physical Science or Life Sciences with specific coursework in Microbiology
  • 5+ years of related experience in medical device (Radiation or Ethylene Oxide) technical role
  • Knowledge of ISO 11137/ISO 11135 or 21 CFR Part 820/1270/1271 or ISO 13485 Design Controls required
  •   Knowledge of International and national standards such as AAMI/ANSI standards, ISO 17665 (Steam Sterilization), 11137 (Radiation Sterilization), 11135 (Ethylene Oxide Sterilization), and others as applicable (i.e. EN)
  • Material selection and protection methods for sterilization, biocompatibility of various components of a biomedical device
  • Demonstrated ability to self-teach, assimilate, and clearly communicate information to an interdisciplinary team
  • Strong computer skills (Microsoft Office Suite - Word, Excel and Outlook) required.
  • Utilization of ERP system is a plus.
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