Scientist 1 Environmental Flex Collector-3531

Parexel International Corporation

Hackensack, New Jersey, United States


Education / experience: Note degree and prior experience

Minimum of HS Diploma with some science experience or prior relevant experience (some combination of education and experience will be considered; can be AS degree with some experience or BS with minimal experience)

EM Sampling Conduct Performance Qualification & Requalification environmental monitoring (EM) activities as necessary for all clean rooms and equipment including Cleaning Verification Equipment sampling (i.e. swab) Perform at rest, In operation & ad hoc sampling (Viable and Non-Viable), any EM in-situ sample studies Transport of EM samples/test samples and in process samples to relevant labs Proficient with equipment for non-viable monitoring (e.g., PMS system, Lighthouse, Met-one, Climet, etc.). and viable monitoring (e.g., SAS, MAS 100, etc.) Perform Utility EM sampling (i.e., N2, compressed air with MAS 100, CG or similar) Support ISO/HEPA testing Verify sample frequency is met on a routine basis

Water Sampling Perform Water sampling activities in support of System Operation and Performance Qualification and relevant phases as necessary (i.e., WFI/USP, Pilot operations, Milli Q systems) for Microbiology & chemistry analysis

Microbiology (this is less important for the collector) Prepare proper documentation (test requests/sample submissions) and log in samples Liaise/coordinate schedules/sample drop off Proficient with incubation and reading of EM samples/Plates Use of MODA Paperless sampling for sample schedule, log-in, plate labeling and paper-based sampling systems (E notebook and hard copy documentation) Autoclave EM supplies as needed Manage Plate inventory and sampling supplies

Other Responsibilities Participate in internal, external, and regulatory/GMP audits and Cleanroom walk throughs Trend data on an ongoing basis and Write Annual EM Reports Write Summary Documents for PQ activities (EMPQ and Water PQ) Revise test procedures, protocols, SOPs, specifications for EM as needed Initiate and support NOE/investigations/Deviations-PSQTS Conducts Metrology functions for EM equipment such as PC and SAS equipment including calibration/PM requests and approvals for use; request POs and send out equipment for outside calibrations; coordinate with Metrology on PM/Cal timelines; maintain records

This position requires an average of four hours per week (16 hours per month) beyond the standard 40-hour week. Compensation for this is built into the salary.

QualificationsEducation / experience: Note degree and prior experience

Minimum of HS Diploma with some science experience or prior relevant experience (some combination of education and experience will be considered; can be AS degree with some experience or BS with minimal experience)

EM Sampling Conduct Performance Qualification & Requalification environmental monitoring (EM) activities as necessary for all clean rooms and equipment including Cleaning Verification Equipment sampling (i.e. swab) Perform at rest, In operation & ad hoc sampling (Viable and Non-Viable), any EM in-situ sample studies Transport of EM samples/test samples and in process samples to relevant labs Proficient with equipment for non-viable monitoring (e.g., PMS system, Lighthouse, Met-one, Climet, etc.). and viable monitoring (e.g., SAS, MAS 100, etc.) Perform Utility EM sampling (i.e., N2, compressed air with MAS 100, CG or similar) Support ISO/HEPA testing Verify sample frequency is met on a routine basis

Water Sampling Perform Water sampling activities in support of System Operation and Performance Qualification and relevant phases as necessary (i.e., WFI/USP, Pilot operations, Milli Q systems) for Microbiology & chemistry analysis

Microbiology (this is less important for the collector) Prepare proper documentation (test requests/sample submissions) and log in samples Liaise/coordinate schedules/sample drop off Proficient with incubation and reading of EM samples/Plates Use of MODA Paperless sampling for sample schedule, log-in, plate labeling and paper-based sampling systems (E notebook and hard copy documentation) Autoclave EM supplies as needed Manage Plate inventory and sampling supplies

Other Responsibilities Participate in internal, external, and regulatory/GMP audits and Cleanroom walk throughs Trend data on an ongoing basis and Write Annual EM Reports Write Summary Documents for PQ activities (EMPQ and Water PQ) Revise test procedures, protocols, SOPs, specifications for EM as needed Initiate and support NOE/investigations/Deviations-PSQTS Conducts Metrology functions for EM equipment such as PC and SAS equipment including calibration/PM requests and approvals for use; request POs and send out equipment for outside calibrations; coordinate with Metrology on PM/Cal timelines; maintain records

This position requires an average of four hours per week (16 hours per month) beyond the standard 40-hour week. Compensation for this is built into the salary.

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


2021-09-15 00:05:39


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