WhiteCrow Research
We are global talent research, insight, and sourcing specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in‑house talent acquisition teams.
About our client Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value‑added sterile injectables that address critical gaps in healthcare delivery.
By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.
Responsibilities
Perform routine environmental monitoring (viable and non‑viable) in classified cleanroom areas (Grade A/B/C/D), including surface and personnel monitoring. Manufacturing is performed inside isolators with surrounding grade C environment.
Collect and test samples from water systems (e.g., purified water, WFI), compressed gases, and other utilities per GMP and site procedures.
Support aseptic process simulations (media fills), including preparation, execution, and recovery/interpretation of microbiological data.
Perform microbiological tests such as bioburden, endotoxin (LAL), and sterility testing for raw materials, in‑process samples, and finished products.
Prepare microbiological media, perform growth promotion testing, and maintain inventory of reagents and supplies.
Maintain laboratory notebooks, logs, and electronic systems in a compliant and organized manner, ensuring adherence to data integrity standards.
Support qualification and validation activities including cleanroom and utility qualifications, method validations, and EM qualification mapping.
Assist in investigations related to microbial excursions or deviations and contribute to the development and implementation of CAPAs.
Support microbiology lab start‑up activities including equipment qualification, SOP development, and execution of technical transfer protocols.
Follow all safety, quality, and regulatory policies, and maintain compliance with cGMP, USP, EU Annex 1, and other applicable guidelines.
Qualifications
Associate’s or bachelor’s degree in microbiology, biology, life sciences, or a related field.
1–3 years of microbiology laboratory experience in a GMP‑regulated pharmaceutical or biotechnology manufacturing environment.
Experience working in sterile environments or supporting aseptic processes preferred.
Familiarity with environmental monitoring equipment (e.g., particle counters, air samplers), microbiological techniques, and lab instrumentation.
Knowledge of cGMPs, data integrity principles, and microbiological standards (USP
,
,
,
,
).
Strong attention to detail and commitment to data accuracy and integrity.
Ability to work independently while collaborating effectively within a team.
Good time management and organizational skills to support multiple tasks and priorities.
Proficiency in the use of Microsoft Office and basic laboratory software systems.
Willingness to work flexible shifts or weekends to support aseptic operations and testing schedules, as needed.
A proactive and patient‑focused mindset with a strong sense of ownership and compliance.
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About our client Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value‑added sterile injectables that address critical gaps in healthcare delivery.
By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.
Responsibilities
Perform routine environmental monitoring (viable and non‑viable) in classified cleanroom areas (Grade A/B/C/D), including surface and personnel monitoring. Manufacturing is performed inside isolators with surrounding grade C environment.
Collect and test samples from water systems (e.g., purified water, WFI), compressed gases, and other utilities per GMP and site procedures.
Support aseptic process simulations (media fills), including preparation, execution, and recovery/interpretation of microbiological data.
Perform microbiological tests such as bioburden, endotoxin (LAL), and sterility testing for raw materials, in‑process samples, and finished products.
Prepare microbiological media, perform growth promotion testing, and maintain inventory of reagents and supplies.
Maintain laboratory notebooks, logs, and electronic systems in a compliant and organized manner, ensuring adherence to data integrity standards.
Support qualification and validation activities including cleanroom and utility qualifications, method validations, and EM qualification mapping.
Assist in investigations related to microbial excursions or deviations and contribute to the development and implementation of CAPAs.
Support microbiology lab start‑up activities including equipment qualification, SOP development, and execution of technical transfer protocols.
Follow all safety, quality, and regulatory policies, and maintain compliance with cGMP, USP, EU Annex 1, and other applicable guidelines.
Qualifications
Associate’s or bachelor’s degree in microbiology, biology, life sciences, or a related field.
1–3 years of microbiology laboratory experience in a GMP‑regulated pharmaceutical or biotechnology manufacturing environment.
Experience working in sterile environments or supporting aseptic processes preferred.
Familiarity with environmental monitoring equipment (e.g., particle counters, air samplers), microbiological techniques, and lab instrumentation.
Knowledge of cGMPs, data integrity principles, and microbiological standards (USP
,
,
,
,
).
Strong attention to detail and commitment to data accuracy and integrity.
Ability to work independently while collaborating effectively within a team.
Good time management and organizational skills to support multiple tasks and priorities.
Proficiency in the use of Microsoft Office and basic laboratory software systems.
Willingness to work flexible shifts or weekends to support aseptic operations and testing schedules, as needed.
A proactive and patient‑focused mindset with a strong sense of ownership and compliance.
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