LL01-061124 - Validation Engineer

Validation & Engineering Group•Allentown, PA

31d•Onsite

About The Position

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 Engineer

Requirements

Bachelor's Degree in Science or Engineering.
Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
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.
SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.

Responsibilities

Experiences in Commercial Secondary Packaging of vials, and pre-filled syringes.
Experience in Process Validation
Responsible for the preparation of the following documents: Validation Project Plan (VPP), and its Summary Report
Combined Validation Strategy (Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis)
Client Specific Operational Qualification, and its Summary Report
Process Performance Qualification (PPQ) Protocol development and execution, as well as the generation of their corresponding summary report.
Identify protocol discrepancies from established product or process standards and provide recommendations for resolving protocol discrepancies
Work closely with process engineering and project managers to coordinate and execute PPQ activities and protocols.
Provide constant communications with all affected departments and personnel regarding validation activities
Other duties may be assigned to meet business needs