Microbiologist

Apex Systems; Philadelphia (Philadelphia County); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading Biotech company in the Philadelphia area is looking for a Microbiologist. Ideal candidates will have a degree in Biology or Biochemistry and at least 1 year of related experience in a regulated environment. Responsibilities include environmental monitoring in cleanrooms, conducting microbiological tests, and ensuring compliance with safety and quality standards. Candidates must be local and able to work on-site in a laboratory environment.

Qualifications

• At least 1 year of related experience in a regulated environment.
• Proficient in performing microbiological statistical analysis.

Responsibilities

• Collect viable and non‑viable samples from manufacturing cleanrooms.
• Participate in the Qualification and/or Validation of Microbiological methods.
• Perform testing under cGMP Guidelines such as Bioburden, pH, and Endotoxin.

Skills

Aseptic technique

Environmental Monitoring

Microbial culture techniques

Microbial staining techniques

Statistical analysis

Microsoft Office proficiency

Education

Degree in Biology, Biochemistry, or Related Field

Job description

Join to apply for the Microbiologist role at Apex Systems

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 some of the following microbiological/analytical methods: Aseptic technique, Cleanroom gowning, Environmental Monitoring, Microbial culture techniques, Microbial staining techniques, Brightfield microscopy, Bioburden, pH, Osmolality, Bacterial Endotoxin Test, 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.

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 [email protected] or 844-463-6178.