Microbiologist

Department

Microbiological Services

Job Title

Microbiologist I

FLSA Status

Exempt

Reports To

Microbiology Manager

1. Role Purpose:

Microbiologist I, will provide practical execution of all activities associated with microbiological testing to support the manufacturing with filled pharmaceutical products, microbial monitoring and oral dose production. This position will engage collaboratively and cross-functionally with other departments to provide microbiological support for activities associated with quality assurance, production, sterilization, facilities maintenance and engineering, method and process validation, product and process development following the cGMP guidelines.

2. Key Duties & Responsibilities:

30% Laboratory Support:

• Responsible for cGMP compliance in Microbiology Department.
• Provide microbiological support to maintain and improve process controls.
• Provide secondary support to Quality Assurance programs for the manufacture of aseptically filled and oral dose pharmaceutical products.
• Sampling raw materials, in-process material, environment and utilities for microbiological analysis.
• Bioburden monitoring of Raw Materials, In-process samples, Manufacturing environment, Utilities and supporting areas.
• Sterility Testing of finished products and In-process samples
• Bacterial Endotoxin Testing of Raw Materials, Finished products and Container/Closures.
• Antimicrobial Effectiveness Testing of finished pharmaceutical products
• Cleaning and disinfection.
• Stability study support.
• Liquid Particulate Matter testing of Finished Drug products.
• Container-closure integrity testing.
• Colony Morphology, Gram Staining and Microbial Identification.
• Assist in Laboratory Investigations related to OOS/OOT results.
• Responsible for Laboratory cleanliness and biohazard removal
• Actively participates in the Laboratory Training Program
• Maintaining Laboratory Inventory (Media, Reagents, Sterile Consumables, Reference Standard and Reference Cultures)
• Media preparation and Microbiological Control
• Preservation of Microbial Isolates

20% Manufacturing Support:

• Provide support for conducting Gowning Qualification studies to support Aseptic Manufacturing operations
• Supports the Aseptic Manufacturing process by conducting Microbial Monitoring of Manufacturing Environment, Surfaces, Personnel and Process utilities (Pharmaceutical Water and Compressed Air)
• Trending the Bioburden results obtained from Environment and Utility monitoring on a regular basis
• Support Microbial Risk Assessment and mitigation process.

20% Validation Support:

• Support the validation of Steam Sterilization (Pharmaceutical Water and Compressed gases), Manufacturing Area (Air and Surfaces), Personnel, Cleaning and Disinfection and Aseptic Manufacturing Process which includes Aseptic Process Simulations.

30% Documentation:

• Document Microbiological Test details and Results, including in applicable interface (Electronic and Paper Documentation) according to Laboratory procedures.
• Initiate Laboratory Investigation in the event of OOS/OOT results.
• Excellent written and oral communication skills
• MS Office applications

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

Education Requirement

Specialization (If any)

Bachelor of Science is preferred

Science or related field

Experience Requirement

2-5 years of scientific experience is preferred.

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

• Strong communication and writing skills including demonstrating proficiency in English.
• Will be required to be fully gowned, including eye and facial covering in sterilized garments and be present in a clean room for hours at a time.

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to Alternate Sit/Stand or Walk, Climbing Ramps/Stairs, Hearing Requirements, Keyboarding, Kneeling, Lifting/Carrying, Pushing/Pulling, Reaching At/Below Shoulder Level and Reaching Overhead. The candidate must also be able to Communicating Verbally and effectively.

b. Work environment:

N/A