Katalyst Healthcares and Life Sciences
Location: Neshanic Station,NJ, USA
Date: 2024-09-21T06:28:02Z
Job Description:
Responsibilities:
- Work with other Information and Technology (IT) teams, Manufacturing, and Quality Control to provide ongoing support, troubleshooting and maintenance of computerized instruments, associated workstations, and software solutions (providing 'on-call' service as needed)
- dminister and maintain lab and/or manufacturing systems user account access requests, as appropriate.
- Responsible for design, implementation, customization, configuration, and support of information systems to align with laboratory/manufacturing workflows, data requirements, and reporting needs.
- Design, develop and maintain scripts to automate tasks and integrate laboratory instruments and information management systems.
- Collaborate with business teams to create and maintain comprehensive documentation for customizations, configurations, mapping workflows, integration system testing, user acceptance testing, SOPs, User Guides, Training Materials, Test Plans, and Validation Documents, while also driving continuous improvement and implementing system enhancements for operational efficiencies and cost reductions.
- Collaborate with the QA/CSV department to support GxP validation processes, including IQ/OQ/PQ activities and test script development/execution, for both on-premises and enterprise systems deployments. Assist or take primary responsibility to participate in the execution of validation protocols/Installation Verification Instructions (IVIs).
- Ensure that computerized systems associated to lab or manufacturing systems are maintained and administered in a manner compliant with corporate and regulatory requirements (including 21 CFR Part 11), including data security protocols.
- Supporting Data Integrity initiatives Audit Trail Reviews, CAPAs, Access Roster reviews, etc.
Requirements:
- Strong background in client support and demonstrated ability to work with clients who have a wide variance in IT and computing skill levels.
- Experience with scripting languages such as PowerShell
- Experience in Pharma/ Biotech industry is a MUST
- Excellent analytical and problem-solving skills.
- Strong collaboration and influence skills to work effectively with cross-functional teams
- bility to work independently, manage multiple tasks, and prioritize effectively.
- Bachelor's degree with 5+ years of working experience as lead administrator or similar role in biotech, pharmaceutical, or life sciences company.