Scientist II, Quality Control - Microbiology

Catalent Pharma Solutions • St. Petersburg, FL

1d • Onsite

About The Position

We have an opportunity for a Scientist II, Quality Control - Microbiology to join our team. The role involves performing microbiological testing of raw materials, in-process materials, finished products, stability, and validation samples according to approved methods and procedures. The position supports environmental monitoring, method suitability, and data integrity in compliance with cGMP standards. This is a hands-on laboratory role requiring strong technical expertise and attention to detail.

Requirements

• Bachelor of Arts or Bachelor of Science with college coursework in Microbiology, Biology, Biological Sciences, or a related life-science discipline.
• At least eight years of experience in a microbiology, pharmaceutical, biotechnology, dietary supplement, or other regulated laboratory environment.
• Extensive hands-on experience with microbiological testing of raw materials and finished products, including preparatory testing, method suitability, recovery assessments, microbial enumeration, and specified microorganism testing in a cGMP laboratory.
• Strong working knowledge and hands-on experience with USP <60>, USP <61>, and USP <62>; experience testing nonsterile pharmaceutical products is strongly preferred.
• Experience with environmental monitoring, including viable air and surface monitoring, and demonstrated ability to statistically trend EM data using approved software and communicate meaningful trends and emerging adverse conditions.
• Experience with microbiological testing of pharmaceutical water systems and manufacturing utilities; aseptic microbiological laboratory techniques; preparation and handling of media, reagents, diluents, neutralizers, and test organisms; growth promotion testing; reference culture handling; and autoclave/sterilization practices.
• Knowledge of bacterial, yeast, and mold recovery, isolation, and preliminary characterization, plus experience coordinating isolate identification through qualified contract laboratories, including handling, documentation, shipment, and review of identification results.
• Extensive experience conducting and writing microbiological laboratory investigations, including excursions, deviations, atypical results, and invalid tests; ability to evaluate root cause and support appropriate corrective and preventive actions.
• Strong technical writing skills and demonstrated experience writing or revising SOPs, microbiological test methods, protocols, investigations, and technical reports.
• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
• Ability to work extended hours or off-hours as required.

Nice To Haves

• Writing laboratory investigations and USP preparatory testing/qualification for chapters <61> and <62> strongly preferred.

Responsibilities

• Perform microbiological testing of raw materials, in-process materials, finished products, stability, and validation samples according to approved methods, procedures, protocols, specifications, and compendial requirements.
• Conduct preparatory testing, method suitability, and nonsterile product testing in accordance with USP <60>, USP <61>, and USP <62>, including sample preparation, dilution, neutralization, recovery, and testing conditions.
• Perform microbiological testing of purified/potable water, compressed gases, manufacturing areas, utilities, and environmental samples; conduct environmental monitoring and statistical trending of EM data.
• Cultivate, recover, isolate, and perform preliminary characterization of bacteria, yeast, and mold, including Gram staining and colony morphology; maintain stock/reference cultures and challenge organisms.
• Prepare microbiological media, reagents, diluents, neutralizers, and test organisms; support growth promotion testing, method transfers, suitability, verification, qualification, and validation activities.
• Interpret, document, and report microbiological results in LIMS and other electronic laboratory systems; perform technical review/auditing of calculations, test records, data, and reports for accuracy, cGMP compliance, and data integrity.
• Initiate, conduct, and write laboratory investigations for microbiological excursions, atypical results, deviations, invalid tests, and environmental monitoring events; evaluate root cause and support corrective/preventive actions.
• Write and revise SOPs, methods, protocols, investigations, and technical reports; support equipment qualification, training, audits/inspections, laboratory safety, inventory, and special projects while working independently with minimal supervision.
• Other duties as assigned.

Benefits

• Competitive Paid Time Off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement – support to finish your degree or earn a new one.
• Employee Resource Groups focusing on Diversity and Inclusion.
• Environmentally friendly, community engagement green initiatives including regular participation in Beach Clean-up.
• Defined career path and annual performance review and feedback process with potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• WellHub program to promote overall physical and mental wellness.
• Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

What This Job Offers

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