Avid Bioservices
Senior Environmental Monitoring Technician
Avid Bioservices, Costa Mesa, California, United States, 92626
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.Your Role:
The
Sr. Environmental Monitoring Technician
performs environmental monitoring and routine microbiological testing within a GMP biopharmaceutical manufacturing organization.Perform environmental monitoring such as non-viable particulates, air viables, surface, temperatures in cleanroom environments within the Manufacturing area per SOP.Perform environmental monitoring for aseptic filling processes according to SOP.Operate monitoring equipment that includes but is not limited to Laser Particle Counter, Viable Air Sampler, Microscope, MilliFlex OasisTest System, Conductivity meter, pH meter and TOC analyzer.Monitor temperatures of Microbiological QC equipment, such as refrigerators, freezers, and cryo-freezers.Read EM (Environmental Monitoring) data and document results on relevant forms.Perform trending and generate trending charts for EM data.Perform Cleaning Verification of cleaned production equipment.Maintain inventory of department supplies and place purchase orders.Perform visual inspection of incoming department supplies in accordance with appropriate material specifications.Perform bioburden testing of samples per USP, EP requirements.Perform Area Release per protocol for campaigned manufacturing areas.Responsible for EM out-of-limit results, such as notification, investigation assistance, re-testing of alert and action OOL’s, etc.Comply with all safety policies, practices, and procedures.Report all unsafe activities to supervisor and/or Human Resources.Participate in proactive team efforts to achieve departmental and company goals.Perform other duties as assigned.Minimum Qualifications:
5+ years of biotech industry experience within a GMP biopharmaceutical manufacturing organization. 2+ years of industry experience working with mammalian cell culture.Ability to apply knowledge of good manufacturing practices and good laboratory practices daily.The understanding and ability to perform aseptic and relevant microbiological techniques such as microbial isolation, streak plate and gram staining.Ability to follow gowning practices for cleanroom environments.Ability to exercise judgment within defined procedures and practices to determine appropriate action.Preferred Qualifications:
Bachelor’s degree (B.A.) or equivalent from four-year college or university, preferably in Microbiology or a relevant life sciences discipline.2+ years of related experience and/or training; or equivalent combination of education and experience.2+ years of industry experience working with mammalian cell culture.Position Type/Expected Hours of Work:
This role is a full-time position operating Monday through Friday. The employee must also, if instructed, be able to work overtime and/or weekends when needed.Compensation:
We offer competitive compensation packages for this role, including a base salary, equity grants, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $25.48-$33.94 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.Your written and verbal skills are out of this world, and you communicate with clarity and confidence.You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
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The
Sr. Environmental Monitoring Technician
performs environmental monitoring and routine microbiological testing within a GMP biopharmaceutical manufacturing organization.Perform environmental monitoring such as non-viable particulates, air viables, surface, temperatures in cleanroom environments within the Manufacturing area per SOP.Perform environmental monitoring for aseptic filling processes according to SOP.Operate monitoring equipment that includes but is not limited to Laser Particle Counter, Viable Air Sampler, Microscope, MilliFlex OasisTest System, Conductivity meter, pH meter and TOC analyzer.Monitor temperatures of Microbiological QC equipment, such as refrigerators, freezers, and cryo-freezers.Read EM (Environmental Monitoring) data and document results on relevant forms.Perform trending and generate trending charts for EM data.Perform Cleaning Verification of cleaned production equipment.Maintain inventory of department supplies and place purchase orders.Perform visual inspection of incoming department supplies in accordance with appropriate material specifications.Perform bioburden testing of samples per USP, EP requirements.Perform Area Release per protocol for campaigned manufacturing areas.Responsible for EM out-of-limit results, such as notification, investigation assistance, re-testing of alert and action OOL’s, etc.Comply with all safety policies, practices, and procedures.Report all unsafe activities to supervisor and/or Human Resources.Participate in proactive team efforts to achieve departmental and company goals.Perform other duties as assigned.Minimum Qualifications:
5+ years of biotech industry experience within a GMP biopharmaceutical manufacturing organization. 2+ years of industry experience working with mammalian cell culture.Ability to apply knowledge of good manufacturing practices and good laboratory practices daily.The understanding and ability to perform aseptic and relevant microbiological techniques such as microbial isolation, streak plate and gram staining.Ability to follow gowning practices for cleanroom environments.Ability to exercise judgment within defined procedures and practices to determine appropriate action.Preferred Qualifications:
Bachelor’s degree (B.A.) or equivalent from four-year college or university, preferably in Microbiology or a relevant life sciences discipline.2+ years of related experience and/or training; or equivalent combination of education and experience.2+ years of industry experience working with mammalian cell culture.Position Type/Expected Hours of Work:
This role is a full-time position operating Monday through Friday. The employee must also, if instructed, be able to work overtime and/or weekends when needed.Compensation:
We offer competitive compensation packages for this role, including a base salary, equity grants, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $25.48-$33.94 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.Your written and verbal skills are out of this world, and you communicate with clarity and confidence.You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
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