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  Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems.
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  Perform risk assessments and impact analysis related to system validation.
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  Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
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  Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities.
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  Manage change control and deviation investigations related to validated systems.
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  Support audits and inspections by regulatory authorities.
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  Maintain validation documentation and ensure traceability throughout the system lifecycle.

Requirements

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  Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
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  5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
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  Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
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  Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.
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  Excellent documentation and communication skills.
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  Ability to work independently and in cross-functional teams.