Job Description

The Environmental Monitoring Technician performs environmental monitoring and routine microbiological testing within a GMP biopharmaceutical manufacturing organization.

• Performs routine and non-routine Environmental Monitoring (EM) such as water sampling, non-viable particulates, viable air, viable surfaces, and gas testing in cleanroom environments within the Manufacturing area at Client’s site, as per applicable standard operating procedures (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.
• Read EM (Environmental Monitoring) data and document results on relevant forms.
• Perform trending and generate trending charts for EM data.
• Participate in validation/verification of controlled environments such as cleanroom, and gowning qualification.
• Perform Quality Control testing such as media and organism qualification as per applicable procedures.
• Assist in USP standard testing including but not limited to water sampling, incubation of samples, and enumeration.
• In cooperation with the Laboratory Manager, responsible for the preventative maintenance of critical EM equipment.
• Monitor test status and conditions as described in Work Instructions and SOPs.
• Record test results accurately and legibly on all documents.
• Technical report writing including text, tables, graphs, and diagrams.
• Report any deviations and/or nonconformities to Management as well as provide possible preventive and corrective measures to prevent future deviations and non-conformities.
• Assist with OOS, NI, CAPA, and Change Control processes in response to Laboratory issues.
• Follow and perform process qualifications and validations for procedures and/or equipment.
• Update procedures for improvement to methods.
• Able to lift at least 50 lbs.
• Assist in the training of new EM Laboratory Technicians.
• Perform bioburden testing of samples per USP, EP requirements.
• Perform Area Release per protocol for campaigned manufacturing areas.
• Comply with all safety policies, practices, and procedures.
• Participate in proactive team efforts to achieve departmental and company goals.
• Driving a company car for offsite work
• Perform other duties as assigned.

Qualifications

Minimum Qualifications:

• 2+ years of biotech industry experience within a GMP biopharmaceutical manufacturing organization.
• Licensed driver with good driving record
• 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.

Additional Information

Position is full-time, working Monday-Friday 8am-5pm, overtime as needed. Candidates currently **living within commutable distance to San Diego, CA **are encouraged to apply.

Compensation Range: $25.48/hr - $30.00/hr

Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.

• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.