Lab Tech II

Job Description

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.

Full-time