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Validation Engineer
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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

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Empleos en Puerto RicoJobs in Puerto Rico
Kelly Science, Engineering, Technology & Telecom

Empleos en Puerto RicoJobs in Puerto Rico Ingenieros
Anasco PR 00600 Anasco
DescripciónDescription 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
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INGENIEROS
Ingenieros (Ingenieros - Otros) Engineering (Engineers - Others)
Sra Maldonado Galeria


AVISO de ClasificadosOnline
Los patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversión o Fraude.
NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email. Evite el Fraude ClasificadosOnline Warning
Employers DON'T ask for money or deposits for work, if they do is a bussiness, invertion or Fraud.
DON'T send money for work, neither offer personal information, by phone or email. Avoid the Fraud

Empleos en Puerto RicoJobs in Puerto Rico
Kelly Science, Engineering, Technology & Telecom

Empleos en Puerto RicoJobs in Puerto Rico Ingenieros
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