QC Lab Equipment Qualification Support
About this role
Company 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 developing Validation 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
- Validation expertise in:
Sterilization
Kaye Validator & Data loggers
Process Validation
Equipment Qualification
Re-qualification
Computer System Validation
Additional Information
Positions available for 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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