Microbiology lab Technician

Description

Daily Work Schedule :Expectations 2nd shift but candidate must be flexible to 1st or 2nd shift – Monday to Friday or Tuesday to Saturday but must be available for any shift/ schedule OT

Job Title : Technician II, Laboratory - MEC

Proposed Job Title :Laboratory Technician II - MEC

Purpose :

Describes the primary goals,objective or function or outputs of this position.

• 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 :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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 :

List required and preferred qualifications up to 10). Include education, skills and experience.

• 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. 

What are the top 3-5 skills, experience or education required for this position?

• Pharmaceutical experience in chemical Lab and/or Microbiology
• BA in Chemical or Microbiology and/or Biology

What is a nice to have (but not required) skill, experience, education, or certification?

• Preferred experience in chemical and or Microbiology

In what type of environment would this individual be working (i.e.: Team; Individual; type of office, etc.) ? Laboratory areas Team

Is overtime offered or required?

• Yes/One weekend a month