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Syner-G · 1 day ago

Validation Engineer

Petersburg, VA

Full-time

Hybrid

Mid, Senior Level

$90K/yr - $150K/yr

4+ years exp

Syner-G is a company dedicated to enhancing the quality of life through breakthrough science and life-enhancing therapies. They are seeking a Validation Engineer to assist with the development and execution of validation protocols, ensuring quality performance and compliance throughout the organization.

Health CareManufacturingPharmaceutical

No H1B

Responsibilities

Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification

Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR)

Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures

Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities

Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments

Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes

Support the resolution of regulatory observations or manufacturing site issues

Execute periodic reviews and requalification for temperature chambers