LL01-081924 Validation Specialist for API Manufacturing - Validation & Engineering Group
Duluth, GA 30097
About the Job
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Specialist for API Manufacturing
Qualifications:
- Bachelor's Degree in Science or Engineering.
- Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Experience in API process development and scale-up.
- Knowledge of Quality by Design (QbD) principles.
- Experience with validation of automated control systems and software.
- Must be proficient using MS Windows and Microsoft Office applications.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
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Excellent written and verbal communication skills, with the ability to effectively document and present validation findings.
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Attention to Detail: High level of attention to detail and commitment to quality.
- SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
- Strong knowledge (according to related area).
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.
Source : Validation & Engineering Group