MV01-082224 Microbiology Analyst (2nd shift)

Veg Group; Manatí (PR); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Microbiology Analyst for the 2nd shift. In this role, you will perform laboratory analyses, ensure compliance with regulations, and maintain quality standards while supporting a clean and safe laboratory environment. The ideal candidate will possess a relevant Bachelor's degree and a minimum of one year of experience in a microbiology lab, along with strong communication skills in both English and Spanish.

Qualifications

• Minimum of 1 year of experience in a pharmaceutical microbiology laboratory.
• Knowledge of aseptic procedures, cGMP, GLP, and FDA regulations.
• Strong communication skills in English and Spanish.

Responsibilities

• Performs laboratory analyses and ensures compliance with regulations.
• Conducts microbial analyses and prepares materials for testing.
• Maintains accurate documentation and manages inventory.

Skills

Aseptic procedures

cGMP

GLP

FDA regulations

Analytical skills

Strong communication skills

Self-management

Visual inspection

Education

Bachelor's degree in Biology

Bachelor's degree in Biotechnology

Bachelor's degree in Medical Technology

Bachelor's degree in Microbiology

Tools

Laboratory Information Management System (LIMS)

Incubators

Sterilizers

pH meters

Microscopes

Biosafety cabinets

Job description

MV01-082224 Microbiology Analyst (2nd shift)

Validation & Engineering Group, Inc. (V&EG) is a leading service provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas such as Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and more.

We are seeking a dedicated, talented individual committed to upholding the highest ethical standards for the following position:

• Microbiology Analyst - 2nd shift (2:00 PM to 10:30 PM)
• Performs laboratory analyses following established procedures and in full compliance with governmental regulations, official compendia, and other policies to generate reliable and timely results, ensuring release deadlines are met, cycle times are reduced, and customer satisfaction is achieved.
• Analyses include bacterial endotoxin, sterility tests, bioburden/microbial limits, growth promotion, particulate matter in parenteral products, microbial identification, pH, osmolality, density, protein concentration, and other related tests for product release.
• Conducts microbial analyses of manufacturing utilities such as water, condensate, compressed air, and nitrogen.
• Prepares and sterilizes materials needed for analysis, including culture media and glassware.
• Performs environmental surveillance of aseptic and oral dosage manufacturing and packaging facilities, including monitoring air, surfaces, and personnel.
• Generates environmental trend reports and discusses findings with manufacturing personnel.
• Audits aseptic techniques and environmental conditions, documenting and initiating corrective actions as needed.
• Trains manufacturing personnel in environmental sampling and aseptic techniques.
• Oversees sample collection from production areas when responsible personnel are unavailable.
• Prepares microbiology and chemistry investigation reports and assists in investigations of out-of-specification results.
• Operates laboratory equipment such as air viability monitors, microbial identification devices, microscopes, biosafety cabinets, autoclaves, incubators, and others.
• Ensures equipment calibration and maintenance are performed regularly.
• Prepares materials and conducts tests according to validation protocols and special requests.
• Maintains accurate documentation of all work, results, and sample custody in compliance with cGMP and Good Documentation Practices.
• Uses Laboratory Information Management System (LIMS) for documentation.
• Maintains organized, clean, and safe laboratory work areas, applying 6S principles.
• Manages inventory, including ordering materials and ensuring expiry dates are respected.
• Supports safety protocols and proper use of safety equipment.
• Reviews data for accuracy and compliance, executing validation and change control procedures as required.
• Participates in the annual product review and CAPA processes related to microbiology.
• Uses testing results for product and raw material disposition decisions.
• Ensures stability studies follow protocols and supports data trending for product shelf-life decisions.
• Supports raw material and packaging material disposition processes.

Knowledge / Skills:

• Bachelor's degree in Biology, Biotechnology, Medical Technology, Microbiology, or related field.
• Minimum of 1 year of experience in a pharmaceutical microbiology laboratory.
• Knowledge of aseptic procedures, cGMP, GLP, and FDA regulations.
• Strong communication skills in English and Spanish, both oral and written.
• Self-motivated with analytical skills and good self-management.
• Proficiency in PC applications (Word, Excel, PowerPoint).
• Technical knowledge of laboratory instruments such as incubators, sterilizers, pH meters, microscopes, and biosafety cabinets.
• Ability to perform accurate visual inspections and recognize microbial growth, with 20/20 vision or corrected.