Validation Engineer
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Full Time
- Ingenieros Engineering / (Ingenieros - Otros) (Engineers - Others)
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Anasco
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Desde $32.00 Hasta $32.00 hr From $32.00 To $32.00 hr -
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Job Purpose:
Plan, execute, and document qualification and validation activities to ensure equipment, systems, utilities, and processes comply with regulatory requirements and industry standards.
Key Responsibilities:
Develop and execute validation protocols (IQ/OQ/PQ) for equipment, systems, and processes.
Author, review, and approve validation documentation including protocols, reports, and SOPs.
Perform risk assessments and gap analyses on systems, processes, or equipment.
Coordinate validation activities with cross-functional teams (engineering, manufacturing, quality, etc.).
Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines.
Support change control processes and evaluate the impact of proposed changes on validation.
Maintain validation master plans and schedules for ongoing compliance.
Participate in audits and regulatory inspections.
Requisitos:
Requirements:
Qualifications: Bachelor's degree in engineering. 2+ years’ experience in validation in the pharmaceutical, biotechnology, or medical device industry (preferred). Strong knowledge of cGMP and regulatory standards (FDA, ISO, etc.). Experience with the validation life cycle, documentation, and project management. Strong analytical, communication, and organizational skills.
Requiere Mucha Experiencia Requires Expert
Requisitos:
Requirements:
Qualifications: Bachelor's degree in engineering. 2+ years’ experience in validation in the pharmaceutical, biotechnology, or medical device industry (preferred). Strong knowledge of cGMP and regulatory standards (FDA, ISO, etc.). Experience with the validation life cycle, documentation, and project management. Strong analytical, communication, and organizational skills.
Requiere Mucha Experiencia Requires Expert
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