IT PLM/R%26D Systems Administrator
Irvine, CA

Job Description

Advanced Sterilization Products (ASP), a member of Fortive, is recruiting for a IT PLM/R&D Systems Administrator- located in Irvine, CA.

Healthcare-associated infections (HAIs) have a devastating personal and economic impact, claiming the lives of 99,000 people in the U.S. each year at a cost of up to $45 billion. Ensuring that all surgical devices are properly sterilized is one-way healthcare workers can help reduce the incidences of HAIs, and Advanced Sterilization Products (ASP) has been partnering with hospitals for decades to safeguard patient health and safety.

ASP has a strong track record of designing and delivering innovative infection-prevention solutions, from low-temperature steam sterilization to high-level disinfection, and is a global market leader setting the standard in sterilization. ASP is based in Irvine, California with offices around the world.

The IT PLM / R&D Systems Administrator establishes and maintains ASPs PLM and R&D IT systems in accordance with the ASP QMS, global regulatory requirements, and industry best practices. As an integral part of the team, the systems admin will work with cross-functional stakeholders to design, validate, implement, and manage changes to and support for ASP's R&D and PLM applications and integrations. Candidate should be a strong leader with the ability to work cross-functionally in a global environment.

Major Duties and Responsibilities:

Under limited supervision, and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

* Work closely with business to gather business requirements and design and implement PLM, CAD, Software Issue and Configuration Mangement, and other R&D software solutions to effectively address those requirements.
* Manage backlog of system change requests, establishing strategy and schedules for system updates based on vendor and user driven updates.
* Implement system configuration updates, including changes as simple as pick list updates to complex workflows incorporating decision tree logic and approval flows.
* Lead assessments of IT systems and system changes for GxP implications and potential risk to quality, compliance, and record integrity. Establish validation plans in accordance with identified impacts and risks.
* Oversee validation activities, such as eliciting user requirements with functional stakeholders and managing validation projects, including oversight of vendors and contractors. Ensure changes are validated according to plans prior to promoting to production.
* Perform regression analysis, verification, and validation testing of new and changed systems, as required.
* Contribute to the development of the company-wide IT Quality processes and tools, including infrastructure qualification, system validation, change management, backup, and management of hosting and service providers.
* Collaborate with other IT teams to design, develop, and support integration between Quality Management systems, R&D systems, and other Enterprise on-premise or cloud applications.
* Provide support to end users for the PLM and R&D applications, including determining root causes of problems as well as fixing issues.
* Responsible for communicating business related issues or opportunities to next management level
* Performs other duties assigned as needed

Education:

Required Minimum Education 1 or Equivalent

8-10 years of related experience and a bachelor's degree is preferred

Years of Related Experience:

Minimum 7 years' experience in establishing and maintaining PLM and R&D systems in an FDA regulated environment.

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:

(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

* Knowledge of relevant regulations (21CFR820, 21CFR11, EU MDR Annex 11) and guidelines (GAMP, PIC/S, ICH)
* Experience with system validation, training, change management for PLM, CAD, and software DevOps software tools
* Ability to travel globally as needed for incidents and meeting with business/IT staff for projects up to 10%.
* Aptitude for learning and capable of working in a fast-paced environment.
* Enthusiastic, highly motivated, quick learning, creative problem solving, proactive and curious.