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:

• Lab Tech II

Purpose:

• Perform microbiological/analytical testing required for water used in the manufacturing process, raw materials, in process samples and final product following specifications.
• Perform microbiological and chemical testing such as bio burden, endotoxin, TOC, pH and conductivity to water samples used in the product manufacturing process and to the final product.
• Perform in process product testing such as bio burden, contamination check and endotoxin. Perform all the facilities and utilities environmental monitoring using Clemet, RCS, and surface sampling.
• Perform gowning sampling as part of routine program and for qualification/routine requirements.
• Perform other microbiological lab testing such as growth promotion and identification of microorganisms.
• Perform analytical testing such as Assay, UDU, Dissolution etc. with experience in Empower.
• Experience in raw material wet chemistry.
• Provide support in method transfer, equipment/instrument qualification and process validation.
• Follow Good Manufacturing Practices (cGMP), safety rules and Good Laboratory Practices (GLP).

Responsibilities:

• Perform microbiological/chemical testing following procedures, methods and specifications within the required time frame.
• Provide support in validations, special sampling, and during planned or unplanned reinstatements.
• Document the test results to all final products, environmental monitoring (EM), water samples following procedures.
• Identify, collect and submit all LIMS required samples.
• Perform identification, growth promotion, and other general microbial testing requirements.
• Perform the general cleaning/maintenance of laboratory equipment such as incubators, refrigerators as required per procedures.
• Maintain the materials, reagents, and media inventory required in the MEC laboratory.
• Comply with all training certifications as required by position requirements.

Qualifications:

• BS degree in Science (major in Biology, Chemistry, Microbiology or Medical Technology).
• Minimum experience of two (2) years in the laboratory, specifically in environmental monitoring (facility and during process).
• Experience in the following testing/methodology is required: bio burden (membrane filtration).
• Experience required with the following equipment (RCS, Climet).
• Experience in Empower CDS.