What are the responsibilities and job description for the Computer System Validation Engineer position at Axelon?
Job Description :
PURPOSE AND SCOPE OF POSITION :
Pay Rate : $60-$63
The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for development of and adherence to system governance procedures. The individual supports multiple IT projects / systems and ongoing work activities of moderate to high complexity.
Reporting into the site Digital Plant organization the candidate will be primarily responsible for managing IT deviations, CAPAs, Investigations, Change Management, computer system validation in support of the vector manufacturing site.
The candidate should have at least 5 years of experience in pharma / biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines. The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing systems development and support.
DUTIES AND RESPONSIBILITIES :
- Support the IT Quality & Compliance for the Cell Therapy Vector manufacturing site.
- Take ownership of deviations, CAPAs and investigations involving the Manufacturing IT Systems.
- Open and lead investigations, triage deviations, and ensure CAPAs are addressed and implemented per requirements.
- Engage technical experts as needed to author and present change requests and author investigations write-ups.
- Support Health Authority and internal audits.
- Collaborate and support the other Site IT groups (Manufacturing IT Systems & MES, Operational Technology Systems & Automation, Enterprise Systems and Integration, IT Site Shared Services) to ensure we can correctly support the manufacturing site.
- Gain proficiency in the IT Service Management platform ServiceNow to create and track service requests, incidents, requests, problems, etc.
- Provide support for operationalizing the manufacturing and peripheral systems.
- Responsible for Computer System Validation of local / site-based systems
- Accountable for the continued compliance of IT systems, procedures and training for vector manufacturing and lab systems.
REQUIRED COMPETENCIES : Knowledge, Skills, and Abilities :
Education and Experience :
dditional Job Requirements :
None
Salary : $60 - $63
