Katalyst CRO
Computer Systems Validation Specialist
Katalyst CRO, Milwaukee, Wisconsin, United States, 53244
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Computer Systems Validation Specialist
role at
Katalyst CRO .
Seniority level: Entry level.
Employment type: Full-time.
Job function: Information Technology.
Responsibilities
Support implementation of a new MES for drug substance manufacturing operations.
Contribute across multiple phases including electronic equipment tracking, electronic batch records, and release-by-exception functionalities.
Support the Quality Engineering workstream to ensure the site is prepared to adopt and sustain MES capabilities within routine production.
Review and support execution and documentation of the CSV Program in accordance with the full CSV lifecycle, Documentation requirements, Validation plans and risk assessments, Functional requirements, Configuration specifications, Testing activities, Change control documentation.
Validation and compliance reviews.
Ensure project deadlines and quality performance standards are met for all CSV-related activities.
Maintain up-to-date knowledge of applicable regulatory requirements impacting CSV.
Review and approve computer systems in the field, including manufacturing and automation systems.
Partner with Automation Engineering and system owners to resolve deviations identified during testing.
Provide timely responses to management and end users regarding project or system inquiries.
Deliver frequent status updates on CSV activities and project progress.
Collaborate with project teams, contractors, system owners, and site operations staff.
Report key activities and issues to the Senior Manager of Quality Engineering.
Qualifications
2+ years of MES experience (required).
Prior experience with Syncade MES strongly preferred.
Hands-on knowledge of CSV within GxP-regulated pharmaceutical manufacturing environments.
Ability to work effectively in a fast-paced, open-office setting with frequent distractions.
Strong communication skills and ability to work in a matrixed team environment.
Ability to coordinate multiple priorities and meet established deadlines.
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Computer Systems Validation Specialist
role at
Katalyst CRO .
Seniority level: Entry level.
Employment type: Full-time.
Job function: Information Technology.
Responsibilities
Support implementation of a new MES for drug substance manufacturing operations.
Contribute across multiple phases including electronic equipment tracking, electronic batch records, and release-by-exception functionalities.
Support the Quality Engineering workstream to ensure the site is prepared to adopt and sustain MES capabilities within routine production.
Review and support execution and documentation of the CSV Program in accordance with the full CSV lifecycle, Documentation requirements, Validation plans and risk assessments, Functional requirements, Configuration specifications, Testing activities, Change control documentation.
Validation and compliance reviews.
Ensure project deadlines and quality performance standards are met for all CSV-related activities.
Maintain up-to-date knowledge of applicable regulatory requirements impacting CSV.
Review and approve computer systems in the field, including manufacturing and automation systems.
Partner with Automation Engineering and system owners to resolve deviations identified during testing.
Provide timely responses to management and end users regarding project or system inquiries.
Deliver frequent status updates on CSV activities and project progress.
Collaborate with project teams, contractors, system owners, and site operations staff.
Report key activities and issues to the Senior Manager of Quality Engineering.
Qualifications
2+ years of MES experience (required).
Prior experience with Syncade MES strongly preferred.
Hands-on knowledge of CSV within GxP-regulated pharmaceutical manufacturing environments.
Ability to work effectively in a fast-paced, open-office setting with frequent distractions.
Strong communication skills and ability to work in a matrixed team environment.
Ability to coordinate multiple priorities and meet established deadlines.
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