Overview
On Site
Full Time
Skills
Manufacturing Operations
Manufacturing
Testing
Test Methods
Good Manufacturing Practice
Reporting
Corrective And Preventive Action
Continuous Improvement
Technical Writing
SAFE
Analytical Skill
Aseptic Technique
Microscopy
ELISA
Biology
Biochemistry
Microsoft Office
Statistics
SAP BASIS
Law
IT Service Management
Innovation
Collaboration
Recruiting
Insurance
Finance
Professional Development
Training
Leadership
CompTIA
Customer Service
Career Counseling
Oracle Application Express
Apex
Job Details
Job#: 2089147
Job Description:
Seeking a Microbiologist to join a Biotech company in the greater Philadelphia area.
POSITION SUMMARY
The Microbiologist will perform routine environmental monitoring in a cleanroom environment and characterize and trend microbial recoveries for the program to support manufacturing operations.
Essential Functions:
Aseptically collect viable and non-viable samples from the manufacturing cleanrooms.
Participate in the Qualification and/or Validation of Microbiological methods and equipment.
Enumerate, isolate, and identify microbial recoveries.
Perform routine testing utilizing Microbiological Test Methods under cGMP Guidelines such as Bioburden, pH, Osmolality, and Endotoxin.
Report and participate in Out of Specification/Out of Trend Investigations.
Participate in Deviations, CAPA's, and other continuous improvement activities.
Draft/Revise SOPs, Reports and other documents using sound technical writing skills.
Participate in general laboratory cleaning and maintenance in support of a safe workspace.
Comply with cGxPs, SOPs, safety requirements, and all company policies.
POSITION QUALIFICATIONS
Competencies:
General understanding and demonstrated proficiencies in of some of the following different microbiological/analytical methods:
o Aseptic technique
o Cleanroom gowning
o Environmental Monitoring
o Microbial culture techniques
o Microbial staining techniques
o Brightfield microscopy
o Bioburden
o pH
o Osmolality
o Bacterial Endotoxin Test
o ELISA
Education and Experience:
Degree in Biology, Biochemistry, or Related Field
At least 1 year of related experience in a regulated environment.
Computer Skills:
Proficient in Microsoft Office products and performing microbiological statistical analysis using an appropriate software.
PHYSICAL DEMANDS
Occasionally lift up to 25 lbs.
Must be able to stand, squat, bend and walk frequently.
Other Physical Requirements:
Must wear appropriate Personal Protective Equipment (PPE) which include Lab Coat, Gloves, Safety Glasses. Must be able to aseptically gown for cleanroom entry and wear the attire for extended periods of time.
WORK ENVIRONMENT
Work is performed on-site in office and laboratory setting.
The noise level in the work environment is usually quiet in office settings and moderate in other situations.
Only local candidates will be considered.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Job Description:
Seeking a Microbiologist to join a Biotech company in the greater Philadelphia area.
POSITION SUMMARY
The Microbiologist will perform routine environmental monitoring in a cleanroom environment and characterize and trend microbial recoveries for the program to support manufacturing operations.
Essential Functions:
Aseptically collect viable and non-viable samples from the manufacturing cleanrooms.
Participate in the Qualification and/or Validation of Microbiological methods and equipment.
Enumerate, isolate, and identify microbial recoveries.
Perform routine testing utilizing Microbiological Test Methods under cGMP Guidelines such as Bioburden, pH, Osmolality, and Endotoxin.
Report and participate in Out of Specification/Out of Trend Investigations.
Participate in Deviations, CAPA's, and other continuous improvement activities.
Draft/Revise SOPs, Reports and other documents using sound technical writing skills.
Participate in general laboratory cleaning and maintenance in support of a safe workspace.
Comply with cGxPs, SOPs, safety requirements, and all company policies.
POSITION QUALIFICATIONS
Competencies:
General understanding and demonstrated proficiencies in of some of the following different microbiological/analytical methods:
o Aseptic technique
o Cleanroom gowning
o Environmental Monitoring
o Microbial culture techniques
o Microbial staining techniques
o Brightfield microscopy
o Bioburden
o pH
o Osmolality
o Bacterial Endotoxin Test
o ELISA
Education and Experience:
Degree in Biology, Biochemistry, or Related Field
At least 1 year of related experience in a regulated environment.
Computer Skills:
Proficient in Microsoft Office products and performing microbiological statistical analysis using an appropriate software.
PHYSICAL DEMANDS
Occasionally lift up to 25 lbs.
Must be able to stand, squat, bend and walk frequently.
Other Physical Requirements:
Must wear appropriate Personal Protective Equipment (PPE) which include Lab Coat, Gloves, Safety Glasses. Must be able to aseptically gown for cleanroom entry and wear the attire for extended periods of time.
WORK ENVIRONMENT
Work is performed on-site in office and laboratory setting.
The noise level in the work environment is usually quiet in office settings and moderate in other situations.
Only local candidates will be considered.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.