Environmental Monitoring Job Description
Environmental monitoring
provides support and expertise to the operations to improve manufacturing aseptic processes (such aseptic practices, environmental monitoring, cleaning and sanitization, Sterilization,…) to deliver products with the highest sterility assurance level.
Environmental Monitoring Duties & Responsibilities
To write an effective environmental monitoring job description, begin by listing detailed duties, responsibilities and expectations. We have included environmental monitoring job description templates that you can modify and use.
Sample responsibilities for this position include:
Performs in-process sampling, review of raw materials and environmental monitoring, Quality Control Chemistry and Quality Control Microbiology
Perform documentation per cGmp
Development and management of the Aseptic Technique training program
Must be able to demonstrate and apply good aseptic technique and cleanroom behavior
Adherence to cGMPs is required at all times during the manufacture of APIs
Adhere to all applicable cGMP guidelines, MSKCC and departmental policies, and CTCEF SOPs
Ability to perform various functions within a cleanroom environment using aseptic techniques
Assists in writing new and revising SOPs
Responsible for media inventory
Ensure that microbiological environmental monitoring and analysis is performed according to Divisional Guidelines and adheres to all applicable regulatory requirements
Environmental Monitoring Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Environmental Monitoring
List any licenses or certifications required by the position: SQF, HACCP, CAPA, GMP, CPR, HAZWOPER
Education for Environmental Monitoring
Typically a job would require a certain level of education.
Employers hiring for the environmental monitoring job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Microbiology, Biology, Biological Sciences, Management, Computer Science, Bioinformatics, Design, Molecular Biology, Civil Engineering, Engineering
Skills for Environmental Monitoring
Desired skills for environmental monitoring include:
Microbiology
Proteins and experience working with large molecules in the laboratory
Aseptic technique and gowning procedures
CGMP
Aseptic technique
Industry practices
Techniques and standards
CGMPs
Environmental monitoring and GMP
USP
Desired experience for environmental monitoring includes:
Associates degree in Life Science, Engineering, or related discipline with 5-10 years relevant biotech or pharmaceutical industry experience
A minimum of a high school diploma/AA with 2 years EM experience in a pharmaceutical/biotech industry
A minimum of 4 years of EM experience in a pharmaceutical/biotech industry or a high school diploma/AA with 6 years EM experience in a pharmaceutical/biotech industry
Communicates information clearly, simply and in a timely manner
Checks reagents for expired chemicals and disposes of any expired reagents
Of staff and operational oversight of group, data review
Environmental Monitoring Examples
1
Environmental Monitoring Job Description
Job Description Example
Our company is looking for an environmental monitoring. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for environmental monitoring
- Collecting samples for laboratory testing
- Monitor, track/trend periodically provide an EM summary report to Sr
- Environmental Monitoring of classified manufacturing cleanrooms
- Utility monitoring of compressed air/gas and water systems
- Quarterly and annual trending evaluations of EM and utility data
- Microbial Enumeration Testing and Method Suitability
- Gel Clot and Kinetic Chromogenic
- Endotoxin Inhibition/Enhancement Testing
- Subculture and characterize microbial isolates
- Performing growth promotion testing of liquid and plated media
Qualifications for environmental monitoring
- Performing peer and technical review of laboratory data
- Writing/reviewing of analytical test methods and SOP’s
- Performing investigations for out of specification results and deviations
- Determining preventative and corrective actions for laboratory investigations
- Assist with customer regulatory audits
- Bachelor's degree with 7 - 9 years related experience required
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Environmental Monitoring Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of environmental monitoring. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for environmental monitoring
- Management and scheduling of EM Monitoring personnel within the department to meet Manufacturing schedule and needs
- Monitoring and trending of Aseptic personnel time spent in the Sterile Manufacturing area
- Development and management of SOPs and forms required to support the Environmental Monitoring of the controlled areas where aseptic manufacturing is conducted
- Environmental isolates, if recovered for the Aseptic area or during gowning monitoring are isolated and then an identification determined using an outside lab
- The Environmental Monitoring Manager is responsible for ensuring that all non-viable and viable data is captured in spreadsheets and trended
- Monthly and quarterly Environmental Mentioning reports are issued to support QA and regulatory requirements
- Supervise laboratory investigations for EM and utilities
- Work with manufacturing to appropriately schedule direct reports work
- Ensure all assigned timelines are met including reviewing, deviations, projects, weekly assignments
- Ensure staff is adequately trained to perform job assignments
Qualifications for environmental monitoring
- Aseptic manufacturing experience preferred
- Knowledge of safety, OSHA, and EPA regulations
- Proficiency with the use of Microsoft Word, Outlook, Excel, PowerPoint
- Strong knowledge of FDA, MHRA, PMDA, aseptic manufacturing regulations and guidelines
- Actively participate and contribute to the Laboratories mission and objectives
- Thorough knowledge of aseptically filled sterile drugs
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Environmental Monitoring Job Description
Job Description Example
Our growing company is looking for an environmental monitoring. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for environmental monitoring
- To serve as Subject Matter Expert for microbiological Testing (Sterility, endotoxin, bioburden, microbial limits tests, etc) and Environmental Monitoring as it relates to microbiology activities
- Quality should be the responsibility of all persons involved in Manufacturing
- All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions
- Must be able to understand the operation and application of all monitoring devices that are automated or manual operation in the department
- Must be able to demonstrate the ability to monitor and document all environmental parameters, such as viable sampling, personnel sampling, temperatures, humidity, and differential pressures under static and dynamic conditions
- Order, receive, quarantine, inspect, label, release and restock raw materials per established SOP’s and controlled material specifications
- Maintain and keep current of raw material Certificate of Analysis (CofA), in-house Certificates of Sterilization (CofS), and Material Safety Data Sheets (MSDS) if applicable
- Prepare and autoclave in-house accessory materials for manufacturing as needed
- Maintain the required technical training and certifications
- Lead and manage the EM team with capacity planning, work schedule prioritization, and optimal resource allocation to ensure an efficient workflow with full synchronization with the Process Unit (manufacturing) while developing training curriculums as needed to assure compliance with Quality, SOP, ICH guidelines, industry standards, and Novartis requirements
Qualifications for environmental monitoring
- Utility system monitoring experience preferred
- Requires sitting, standing, and bending and a normal range of hearing and vision
- Experience of training & coaching in analytical techniques, instrumentation troubleshooting
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
- A minimum of 8-10 years related experience in Quality Control/Quality Assurance with strong lab experience in a pharmaceutical industry preferred
- This role requires an initial training period on dayshift for approximately one month
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Environmental Monitoring Job Description
Job Description Example
Our company is looking for an environmental monitoring. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for environmental monitoring
- Provide direction and technical guidance on evaluating and troubleshooting routine and non-routine technical problems, leading deviation and issue resolution to support manufacturing investigations, overseeing method validation/transfer, and equipment/facility/cleaning qualifications
- Perform analytical review of lab work by authoring, reviewing and approving EM studies and reports
- Promote effective communication with all levels of the organization through collaboration, networking, and developing innovative methods to assure a high customer service level
- Spearhead Lean Lab certification/re-certification and provide leadership for QC process improvement projects, safety, and metrics measurement
- May assist the QC Team Lead with budgeting, resource planning and performance evaluation of staff
- Promote Thermo business for the assigned products and territory to realize AOP bookings and revenues
- Develop the account management activities for the territory to drive account expansion and penetration
- Develop and build key accounts within the pharmaceutical, chemical, iron & steel and academic sectors
- Maintain accurate and current records of proposals, opportunities, accounts, contacts, leads and actions through Salesforce.com CRM system
- Plan, organize and accurately forecast territory results on a weekly basis
Qualifications for environmental monitoring
- Ability to accomplish the described duties through the use of appropriate laboratory equipment
- Expert level understanding of the Clean Air Act’s emissions testing, monitoring, recordkeeping and reporting requirements
- Proven ability to diplomatically and assertively handle challenging situations with regulatory agencies, the public, or company personnel
- Proven ability to work in a geographically diverse team environment
- Aseptic processing experience and training preferred
- BA/BS in Science
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Environmental Monitoring Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of environmental monitoring. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for environmental monitoring
- Work closely with the Marketing department to identify and assess new opportunities for existing products opportunities for new product development
- Interface with Field Service to exchange customer information and ensure adequate support of the account base
- To ensure that appraisals and performance reviews are carried out in accordance with company policy
- To perform checking & verifying of analytical data in accordance with in-house SOPs
- Accountable for maintaining a safe work environment in a GMP-FDA regulated environment
- Management of environmental monitoring of production facilities including utility monitoring programs and input into clean room qualifications and protocols
- Developed and implement programs for trending of EM and utility data
- Responsible for reporting and investigation of environmental excursions for all classified areas utilities
- Developed organizational and training strategies to provide maximum testing efficiency
- Manage performance and established metrics for the environmental monitoring laboratory to manage the efficiency and effectiveness of the group and/or individual while fostering a culture of continuous improvement
Qualifications for environmental monitoring
- 1-3 years of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations
- Evidence of good oral and written communication skills, effective presentation of concepts and ideas, interpersonal and conflict resolution skills
- Collect Room EM samples for EM routes that are assigned to downstream manufacturing
- Collect at frequency specified by site procedure
- Transport to predefined designated area
- Maintain inventory of sample collection material , media, equipment, IPA