Pharma CSV Specialist — Validation & Compliance Expert

Validation & Engineering Group; New Albany (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

A services supplier in pharmaceutical and biotechnology sectors is looking for a dedicated individual with a Bachelor's degree in Science or Engineering and a minimum of 5 years of relevant experience. The successful candidate must be fully bilingual in English and Spanish and possess strong knowledge in regulatory compliance. Familiarity with essential tools like Ellab Data Loggers and Kneat is essential. This position may require working during extended hours including weekends and holidays.

Qualifications

• 5+ years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Strong knowledge of Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
• Available to work extended hours, including weekends and holidays.

Skills

Bilingual (English/Spanish)

Technical Writing

Knowledge of cGxP

MS Windows proficiency

Experience in Design Documentation

Education

Bachelor's Degree in Science or Engineering

Tools

Ellab Data Loggers

Kneat

Maximo

Keyence Microscopes

Job description

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.

Job Description

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Qualifications

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experiencein direct pharmaceutical, medical device or biotechnology industries.
• Experience indirect process / laboratory areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• 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, CSV protocols development and execution, deviations and reports generation.
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
• Strong knowledge of Ellab Data Loggers, Star Oddi Sensors, Keyence Microscopes, Kaye Data Loggers, X-Ray, Bar Code Verifiers.
• Experience with Kneat, CDOCS, Maximo.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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