Talentify
Microbiology Lead 2nd Shift
Talentify, Birmingham, Alabama, United States, 35275
Job Title:
Microbiology Lead 2nd ShiftJob Description:Provide Microbiology support for routine activities:Environmental Monitoring:
Monitor classified areas using active/passive air sampling methods and RODAC/swab surface sampling methods for the detection of bacteria and fungi. Utilize Climet air sampling methods for the detection of non-viable particulates. Trend data to detect anomalies and characterize the transient and resident microflora.Utilities Testing:
Sample and test USP water, clean steam, and Water for Injection (WFI) for total microbial count, absence of enteric organisms, presence of endotoxins, and total organic content (TOC). Sample and test nitrogen and process air for total microbial count, non-viable particulates, dew point, and hydrocarbons content.Microbial Identification and Contamination Control:
Demonstrate knowledge of microbial classification and utilize classical methods for the identification of microorganisms. Enter and analyze data in software systems such as Microbiology Information Management Systems (MIMS) to trend data, detect anomalies, and characterize the transient and resident microflora. Document test results and conclusions in accordance with cGMP training. Show aptitude to learn industry practices in compliance with Federal and International regulations applicable to environmental monitoring. Proficient in identifying bacteria and fungi using microscopy and phenotypic/genotypic methods. Maintain ATCC/NTCC microorganisms and in-house environmental isolates.Leadership:
Lead small groups in routine testing. Periodically observe personnel activities in cleanrooms and propose procedural changes and continuous improvement efforts directed towards contamination control. Assist in investigations related to Environmental Monitoring and Utility testing excursions. Improve lab efficiency by updating documents and creating and sustaining new processes. Review operational processes to gauge steps for aseptic intervention.Regulatory Compliance:
Review environmental monitoring trends to determine effective contamination management in manufacturing areas. Monitor aseptic process training of personnel with access to cleanrooms. Identify training gaps and suggest improvements. Possess sound knowledge of Federal and International regulations (such as EU Annex I) applicable to contamination control and maintaining a suitable environment for pharmaceutical manufacturing. Serve as subject matter expert (SME) and lead investigations related to EM and utility testing excursions. Support review and approval of EM trend reports, protocols, and SOPs.Safety and Documentation:
Conduct all laboratory activities safely, using MSDS to establish chemical hazards. Observe appropriate laboratory procedures and report incidents threatening the safety of laboratory personnel. Follow cGMP regulations and procedures; generate and maintain thorough and accurate documentation in support of cGMP activities. Contribute to the safety, quality, and appearance of laboratory and other working spaces by adhering to all company safety, health, and environmental policies, procedures, and directives. Ensure training and growth progression through self-studies, OJTs, instructor-led training, and other development resources.Hard Skills:Laboratory experience (industrial or academia)Environmental monitoring or food lab experience (USDA, FDA)Microbiological procedures and PPEExperience with SOPs and documentationSoft Skills:Interpersonal skillsTeam-oriented skillsConflict resolutionJob Type:
This is a Contract-to-Hire position with a duration of 9 Month(s).Work Site:
This is a fully on-site position in Birmingham, Alabama.Work Environment:
Pharmaceutical lab with cleanroom. Team-oriented environment. 2nd shift.About Actalent:
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion:
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email
actalentaccommodation@actalentservices.com
for other accommodation options.
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Microbiology Lead 2nd ShiftJob Description:Provide Microbiology support for routine activities:Environmental Monitoring:
Monitor classified areas using active/passive air sampling methods and RODAC/swab surface sampling methods for the detection of bacteria and fungi. Utilize Climet air sampling methods for the detection of non-viable particulates. Trend data to detect anomalies and characterize the transient and resident microflora.Utilities Testing:
Sample and test USP water, clean steam, and Water for Injection (WFI) for total microbial count, absence of enteric organisms, presence of endotoxins, and total organic content (TOC). Sample and test nitrogen and process air for total microbial count, non-viable particulates, dew point, and hydrocarbons content.Microbial Identification and Contamination Control:
Demonstrate knowledge of microbial classification and utilize classical methods for the identification of microorganisms. Enter and analyze data in software systems such as Microbiology Information Management Systems (MIMS) to trend data, detect anomalies, and characterize the transient and resident microflora. Document test results and conclusions in accordance with cGMP training. Show aptitude to learn industry practices in compliance with Federal and International regulations applicable to environmental monitoring. Proficient in identifying bacteria and fungi using microscopy and phenotypic/genotypic methods. Maintain ATCC/NTCC microorganisms and in-house environmental isolates.Leadership:
Lead small groups in routine testing. Periodically observe personnel activities in cleanrooms and propose procedural changes and continuous improvement efforts directed towards contamination control. Assist in investigations related to Environmental Monitoring and Utility testing excursions. Improve lab efficiency by updating documents and creating and sustaining new processes. Review operational processes to gauge steps for aseptic intervention.Regulatory Compliance:
Review environmental monitoring trends to determine effective contamination management in manufacturing areas. Monitor aseptic process training of personnel with access to cleanrooms. Identify training gaps and suggest improvements. Possess sound knowledge of Federal and International regulations (such as EU Annex I) applicable to contamination control and maintaining a suitable environment for pharmaceutical manufacturing. Serve as subject matter expert (SME) and lead investigations related to EM and utility testing excursions. Support review and approval of EM trend reports, protocols, and SOPs.Safety and Documentation:
Conduct all laboratory activities safely, using MSDS to establish chemical hazards. Observe appropriate laboratory procedures and report incidents threatening the safety of laboratory personnel. Follow cGMP regulations and procedures; generate and maintain thorough and accurate documentation in support of cGMP activities. Contribute to the safety, quality, and appearance of laboratory and other working spaces by adhering to all company safety, health, and environmental policies, procedures, and directives. Ensure training and growth progression through self-studies, OJTs, instructor-led training, and other development resources.Hard Skills:Laboratory experience (industrial or academia)Environmental monitoring or food lab experience (USDA, FDA)Microbiological procedures and PPEExperience with SOPs and documentationSoft Skills:Interpersonal skillsTeam-oriented skillsConflict resolutionJob Type:
This is a Contract-to-Hire position with a duration of 9 Month(s).Work Site:
This is a fully on-site position in Birmingham, Alabama.Work Environment:
Pharmaceutical lab with cleanroom. Team-oriented environment. 2nd shift.About Actalent:
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion:
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email
actalentaccommodation@actalentservices.com
for other accommodation options.
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