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Computer System Validation Specialist
2 months ago
We are seeking a skilled Computer System Validation Engineer to join our team at Eclaro. As a key member of our team, you will be responsible for leading and executing validation activities for GxP electronic systems and applications.
Key Responsibilities:
- Lead routine CSV lifecycle activities, coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.
- Author, review, and/or approve applicable CSV documentation.
- Assist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
- Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities.
Requirements:
- Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).
- Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.).
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication.
- Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
- Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.
Education and Experience:
- Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.
- Must have experience with Computer system validation of MES.
- Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
About Eclaro:
Eclaro is an equal opportunity employer and values diversity. We do not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
