Validation Engineer

Net2Source Inc
: 5+ Years
: Andover, MA, USA
Salary : Salary Not Disclosed By Employer
Openings : 1
Job Function : Biomedical Engineer
Industry : Biopharmaceuticals
Qualification : Biotechnology, Any Graduation
Certification Required (if any) : Not Mentioned
Notice Period : Not Mentioned

Key Skills

Human Resources (HR), Sterilization

Job Description

Validation Engineer

We are hiring for one of our esteemed pharma client for Validation Engineer Position.

·         Provide support for the Revalidations of Process Equipment, and the Requalification of Controlled Temperature Units (CTUs), Critical Utility Systems, and Curtained HEPA Areas (CHAs). As necessary, support Sterilization Validation, Equipment/Utilities Validation and Shipping Studies.

·         This position will provide support for the Revalidation and Requalification Programs at the Pfizer Andover site.

·         Revalidation of Process Equipment: Fermenters, UF/DF Skids, CIP Skids, Chromatography Skids, Tanks, etc.

·         Requalification (temperature mapping) of CTUs: Incubators, Refrigerators, Freezers, and Environmental Rooms.

·         Requalification’s of Critical Utility Systems: Compressed Gases (Carbon Dioxide, Oxygen, and Nitrogen), HVAC, WFI, and Clean Steam.

·         Perform Air Flow Visualization Smoke Studies.

·         Support Sterilization Validations: Autoclaves, Process Equipment, Depyrogenation Systems and Transfer Lines.

·         Support Equipment/Utilities Validations.

·         Support Shipping Studies

·         Work with Operations, Quality, Technical groups, and other site/network groups as required, assisting in establishing business and compliance requirements of Revalidation and Requalification activities.

·         Plan and coordinate the Revalidation/Requalification work assigned.

·         Technical understanding of process and equipment to be qualified.

·         Accountable for quality of work performed.

·         Perform the work in accordance to all the compliance requirements and in a safe manner.

Company Info.

Net2Source Inc

Staff Augmentation, Direct Hires, RPO, Contingent Hiring, Application Development, MSP/VMS Sales, Product Development, Project Management, Infrastructure Management, IT Support Services, Call Center Services, BPO, Coshoring and VMO, recruitment, RPO, Managed Services, Direct hiring, and payroll

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