Scientist - Biology/Microbiology

Flexible & Integrated Technical Services, LLC • Gurabo, PR

5d • Onsite

About The Position

This role is for Biology/Microbiology services within the Manufacturing area. The ideal candidate will perform laboratory analysis, including but not limited to Microbial Purity Test, Bacterial Endotoxin Test, Biological Indicators certification and analysis, Endotoxin test, and other applicable tests for all raw materials, drug substances, and products, in accordance with internal and external regulations, policies, and supply chain cycle time goals. The position also involves complying with laboratory schedules for raw materials, product testing, utilities, environmental monitoring, and special projects. Responsibilities include performing water sampling and analysis, keeping trend analysis updated, working on test method validation or special projects, handling environmental and utilities sampling and testing, and processing validation and cleaning & trend analysis. The scientist will identify all microbial growths detected, perform all laboratory activities under cGMP practices and compliance policies, conduct media preparation, growth promotion tests, provide support in investigations and manufacturing issues, ensure equipment is qualified, calibrated, and in good condition, and verify that culture media used for testing are approved and within expiration date. The role requires operating laboratory equipment such as autoclaves, pH meters, microscopes, balances, and identification systems (manual/automatic) and computerized systems. Additionally, the scientist will prepare all culture media, reagents, stock cultures, and materials required for testing, if required.

Requirements

• Bachelor’s degree in Natural Sciences
• At least 2+ years of previous experience in Biology/Microbiology activities within the Pharmaceutical or Medical Device industry.
• Experience in Biological Agent
• Experience in Assays
• Experience in Biomarker
• Experience in Growth promotion
• Experience in Endotoxin
• Experience in Bioburden testing
• Bilingual: (Spanish and English)

Nice To Haves

• Treats everyone they meet like family, especially resources, clients and team members.
• Customer service skills.
• Full of bright ideas and eager to innovate.
• Always bringing top-quality results to the table.

Responsibilities

• Perform laboratory analysis, including Microbial Purity Test, Bacterial Endotoxin Test, Biological Indicators certification and analysis, Endotoxin test, and other applicable tests for all raw materials, drug substances, and products, in accordance with internal and external regulations, policies, and supply chain cycle time goals.
• Comply with Laboratory Schedules for raw materials, product testing, utilities, environmental monitoring, and special projects.
• Perform water sampling and analysis; keep trend analysis updated as required; work on test method validation or special projects; handle environmental and utilities sampling and testing; and process validation and cleaning & trend analysis.
• Identify all microbial growths detected, perform all laboratory activities under cGMP practices and compliance policies, conduct media preparation, growth promotion tests, provide support in investigations and manufacturing issues, ensure that equipment is qualified, calibrated, and in good condition for its use, and verify that culture media used for testing are approved and within expiration date.
• Operate laboratory equipment, such as autoclaves, pH meters, microscopes, balances, and identification systems (manual/automatic) and computerized systems.
• Prepare all culture media, reagents, stock cultures, and materials required for testing, if required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level