Job Title:

Computer Systems Validation Engineer/Specialist\nWe are looking for a validation engineer with experience in computer systems validation work with preference to those familiar with MODA and/or LabWare interfaces.\nTechnical duties include developing and implementing validation protocols, adhering to domestic and international GMP regulations. It also includes communicating with impact, operating collaboratively while holding themselves and other team members accountable and proactively taking steps to learn & grow based on feedback. The individual will collaborate with cross-functional team members such as Quality Systems, Quality Control, Project management and other technical disciplines to lead execution of assigned validation deliverables of the projects.\nExperience essentials:\n

Bachelor's degree in a technical discipline, preferably engineering or biological sciences and a minimum of 5 years pharmaceutical and/or biopharmaceutical industry experience. Corresponding relevant experience in lieu of a bachelor's degree will be considered when assessing candidates.\n
Applies thorough understanding of cGXPs, GAMP5, S88 and 21CFR Part 11 (as applicable).\n
In-depth knowledge of core principles of validation programs\n

Regulatory Compliance:

Understanding, adhering to and maintaining compliance with cGMP standards is fundamental. Position will navigate complex regulatory requirements to ensure that all changes to

LIMS/MODA

systems meet industry standards.\n

Experience in Trackwise, Veeva, Kneat, ALM or other common electronic documentation systems\n
Experience in Microsoft Teams operations\n
Strong written and verbal communication skills are desired.

\nProject-Specific Scope Details\nProject 1 (Bioburden Alignment): The core deliverable is the transition of Master Data configuration in MODA to handle numeric values (> 250/> 50) instead of text-based \"TNTC\" flags. Support must ensure that existing trending reports do not break during this shift. This is an Opex project and will be funding via Quality\nProject 2 (Growth Direct Interface): This requires specific deliverables for Data Integrity verification. The CSV support must prove that counts from the Growth Direct camera are accurately \"mapped\" to the corresponding sample record in MODA without manual entry. Liz to confirm with Tyler Zbinden if this project has capital funding that could be charged to.\nProject Phase\nMajor Action / Task\nSpecific Deliverable(s)\nPlanning\nDefine alignment with Annex 1 and Global procedures for both projects.\nValidation Plan (VP) or Addendum\nRequirements\nCapture new bioburden numeric limits and Growth Direct interface needs.\nUser Requirement Specification (URS)\nTest Authoring\nBuild detailed verification steps for methods and data interfaces.\nOQ/PQ Protocols; Client ALM Test Scripts (linked to requirements).\nExecution\nFormal testing of the MODA system configuration and the instrument link.\nExecuted Test Logs; Traceability Matrix (TM).\nDefect Mgmt\nDrafting defects within ALM /protocol deviations.\nDefect Reports\nPost-Approval\nFormalize the system's \"ready for use\" status.\nValidation Summary Report (VSR), verifying completion of associated SOPs\n

Key CSV Deliverables & Activities:

Full Validation Lifecycle Management:

Authoring and routing GAMP 5 documents, including Validation Plans, URS\nTest Script Development (ALM): Designing and managing all manual and automated test scripts within Client ALM with full traceability.\n

Interface & Data Integrity Verification:

Specifically validating the secure data mapping and transfer between the Growth Direct instrument and MODA.\n

Comprehensive Regression Testing:

Ensuring that new method configurations and the instrument interface do not impact existing MODA functionality or data integrity.\n

Defect & Deviation Management:

Managing root cause analysis and documentation for any issues identified during the execution phase.\n

Cross-Functional Coordination:

Acting as the technical bridge between Business SMEs and Admin SMEs to translate requirements into validated system states.

EEO:

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