Lab Equipment Validation Engineer – CSV/IOQ Focus

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

Job summary

A leading services supplier in the pharmaceutical sector is seeking a professional for Laboratory Equipment Validation. The role involves developing and executing Validation Plans, Risk Assessments, and related documentation. Candidates must have a Bachelor's Degree in Chemistry or a related discipline, alongside experience in validation and strong technical writing skills. The position is based in Puerto Rico, qualifying applicants should have a solid understanding of GMP regulations and apply their technical knowledge effectively.

Qualifications

• Experience developing Validation Plans, Risk Assessments, and related documentation.
• Validation experience in Computer Systems.
• Strong knowledge of 21 CFR Part 11.

Responsibilities

• Develop and execute Laboratory Equipment Validation.
• Create and manage Validation Plans and documentation packages.
• Execute validation protocols and produce necessary reports.

Skills

Validation Plans Development

Risk Assessments

Technical Writing

GMP 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.
• 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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