Quality Operations - Environmental Monitoring Manager
- Charlottesville, VA
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Manager of Environmental Monitoring (EM) for Elkton, Va Manufacturing site provides oversight and direction in regards to the environmental state and directly supervises Environmental Monitoring Technicians. The Manager works with the Integrated Production Teams (IPT) to ensure appropriate routine EM and response to environmental excursions within the facility or utility systems. He/She is responsible for ensuring standardization of work for the EM Technicians as well as understanding and providing awareness to the technicians of environmental trends and concerns. He/She is directly responsible for a team of 10-15 hourly employees who carry out the EM/Utilities program requirements including sampling, reading plates, investigations, and interactions with the microbiology laboratory and IPTs.
The Manager of Environmental Monitoring is knowledgeable in Federal and other regulatory agency requirements, current Good Manufacturing Practices (cGMPs), and our company Guidelines and Sterile Standards to assure that all areas remain in compliance. The Manager of Environmental Monitoring will be the primary point person for the EM. He/She will be responsible for ensuring the team remains in an inspection-ready state for regulatory agencies. Specific responsibilities include but are not limited to the following:
- Directly responsible for a team of 10-15 hourly employees who perform the sampling and reading of plates to enable a successful EM/Utility program
- Manage routine shift coverage, overtime, and time approvals for all hourly employees.
- Manage training program for employees as well as employee development.
- Participate in investigations to drive to the root cause and require and perform Corrective Action and Preventive Action (CAPAs) as appropriate.
- Ensures standardization and effectiveness sampling program as well as response level cleaning.
- Provides oversight of environmental trends and environmental annual reviews. Implements corrective actions as appropriate.
- Works with IPTs and EM Technicians to maintain effective communication ensuring a robust environmental control program
Position Qualifications :
Education Minimum Requirement:
Bachelors or advanced degree in Microbiology, Biology, or Environmental Science and/or Engineering
Required Experience and Minimum Requirements;
- Bachelors or advanced degree in Microbiology, Biology, or Environmental Science and/or Engineering
- At least 2 years of experience in Environmental / Control Monitoring, cGMP Microbiology laboratory, quality or technology-related position within sterile or aseptic operations
- Familiarity with aseptic gowning & processing
- Understanding of cGMPs and/or regulatory requirements as they apply to sterile manufacturing
- Skills with data management and trending computerized systems, and Microsoft Office Systems
- Evidence of leadership skills coupled with good oral and written communication skills.
Preferred Experience and Skills:
- Experience speaking with Regulatory Inspectors
- Familiarity with vaccine, biologics and sterile pharmaceutical processing
- Familiarity with U.S. Pharmacopoeia (USP) Chapters on EM and Utilities and Industry best practices such as the Parenteral Drug Association (PDA) white papers
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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No Travel Required
Flexible Work Arrangements:
1st - Day
Valid Driving License:
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