Company:
Katalyst Healthcares & Life Sciences
Location: Branchburg Township
Closing Date: 20/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities:
This role is essential in ensuring the seamless operation of our laboratory and manufacturing systems.
The ideal candidate will possess a strong technical background, excellent problem-solving abilities, and a commitment to delivering exceptional support.
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)
Administer 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 is MUST.
Experience with scripting languages such as PowerShell
2-6yrs of 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
Ability 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.
This role is essential in ensuring the seamless operation of our laboratory and manufacturing systems.
The ideal candidate will possess a strong technical background, excellent problem-solving abilities, and a commitment to delivering exceptional support.
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)
Administer 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 is MUST.
Experience with scripting languages such as PowerShell
2-6yrs of 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
Ability 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.
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