Laboratory Validation Specialist – IOQ/CSV & GMP Expert

Validation & Engineering Group; Juncos (PR); On-site; Full time

Job summary

A leading solutions provider in pharma and biotech is seeking a professional to develop and execute Laboratory Equipment Validation in Puerto Rico. The role requires expertise in creating Validation Plans, conducting Risk Assessments, and preparing compliance documentation. Candidates must hold a Bachelor's degree in Chemistry or related discipline and have validation experience with various equipment. Knowledge of GMP regulations and strong technical writing skills are essential. Equal Opportunity employer.

Qualifications

• Develop Validation Plans, Risk Assessments, IOQ, and Traceability Matrix.
• Execute validation protocols for laboratory equipment.
• Prepare documentation packages for validation activities.

Responsibilities

• Develop and execute Laboratory Equipment Validation.
• Create documentation including Validation Plan and SOPs.
• Ensure compliance with GMP and regulatory requirements.

Skills

Validation experience with UV Analyzer

Experience with Viable and Non-Viable Particle Monitoring Equipment

Validation experience in Computer Systems

Technical Writing Experience

Strong knowledge in GMPs regulations

Education

Bachelor Degree in Chemistry or related discipline

Job description

Validation & Engineering Group,Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical,and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, manufacturing operations among other services.

Job Description

Development and execution of Laboratory Equipment Validation. Development of Validation Plan, Risk Assessment, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs. Execution of related validation protocols. Development of documentation packages for all activities, including: Original format documents, approved document and applicable drawings.

Qualifications

• Bachelor Degree in Chemistry or related discipline
• Experience developingValidation Plans, Risk Assessments, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs.
• Mist have validation experience in the following equipment:
• ** UV Analyzer
• ** Viable and Non-Viable Particle Monitoring Equipment
• Validation Experience in Computer Systems
• 21 CFR Part 11 practical knowledge
• Strong knowledge in GMPs regulations
• Technical Writing Experience

Additional Information

Positions availablefor Puerto Rico.

Only candidates that meet the minimum requirements will be considered.

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.

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