Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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 Engineer

Job Summary:
We are looking for a talented Validation Engineer with solid experience in CQV and Qualification of Autoclaves, including developing Sterilization Cycles for an Fsub0 of 15 or more. The ideal candidate should be committed to working under the highest ethics standards and be willing to occasionally work extra hours and weekends.

Qualifications:

• Bachelor's Degree in Engineering.
• Minimum of 3 years of experience in direct pharmaceutical, medical device, or biotechnology industries.
• Experience in direct process/manufacturing areas.
• Proficiency in English and Spanish with excellent oral skills.
• Proficient in MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance with an understanding of their application to regulatory compliance.
• Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations, and reports generation.
• Familiarity with SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT), and Site Acceptance Test (SAT).
• Strong knowledge in relevant areas.
• Technical writing skills and investigations processes.
• Willingness to work extended hours, weekends, and holidays.

Responsibilities:

• Develop and execute protocols for the Validation of Autoclaves.
• Ensure compliance with regulatory standards.
• Participate in FAT and SAT processes.
• Write and review Design Documentation.
• Conduct risk assessments and ensure data integrity.