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

Duration: 3 months (On Site)

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

Qualifications:

• 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.