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Description: Position Summary:
The Environmental Monitoring Technician I will independently perform tasks related to environmental monitoring to support the regulatory requirements of cell and gene therapy facilities. This position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.
Operate various equipment in GMP facilities supporting GMP operations. Prepare documentation of activities, actions, and results Ensure proper documentation practices during job activities Read and execute SOPs (Standard Operating Procedures) Maintain accurate and complete records (for example : laboratory notebooks, quality records, sample receipts) Complete required training Guide others on SOPs (Standard Operating Procedures), control documents, and / or other work instructions Coordinate activities of support groups Perform regular audits of SOPs (Standard Operating Procedures) and / or work instructions Perform routine sampling activities and associated data entry Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities Read and interpret diagrams, drawings, and other schematics Recommend and initiate activities to ensure area and equipment are maintained in a state of compliance Provide feedback on service and quality issues on a timely basis This position requires shift work with weekends and occasional extended shifts with possible short-notice schedule shift changes
Minimum Qualifications: Bachelors Degree in Life Sciences. Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language Good attention to detail is required. Must be capable of keeping accurate records and performing mathematical calculations. One to two years of experience in a pharmaceutical production environment.
Preferred Qualifications: Preferred Biology degree Two years of experience in a pharmaceutical production environment. Experience working in a LEAN manufacturing environment Knowledge of cGMPs and FDA policies / procedures
Operate various equipment in GMP facilities supporting GMP operations. Prepare documentation of activities, actions, and results Ensure proper documentation practices during job activities Read and execute SOPs (Standard Operating Procedures) Maintain accurate and complete records (for example : laboratory notebooks, quality records, sample receipts) Complete required training Guide others on SOPs (Standard Operating Procedures), control documents, and / or other work instructions Coordinate activities of support groups Perform regular audits of SOPs (Standard Operating Procedures) and / or work instructions Perform routine sampling activities and associated data entry Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities Read and interpret diagrams, drawings, and other schematics Recommend and initiate activities to ensure area and equipment are maintained in a state of compliance Provide feedback on service and quality issues on a timely basis This position requires shift work with weekends and occasional extended shifts with possible short-notice schedule shift changes
Minimum Qualifications: Bachelors Degree in Life Sciences. Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language Good attention to detail is required. Must be capable of keeping accurate records and performing mathematical calculations. One to two years of experience in a pharmaceutical production environment.
Preferred Qualifications: Preferred Biology degree Two years of experience in a pharmaceutical production environment. Experience working in a LEAN manufacturing environment Knowledge of cGMPs and FDA policies / procedures