Environmental Monitoring Technician
Environmental Monitoring Technician
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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 Clients 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:
- Bachelors 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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
