Requisition ID: QUA008253
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering 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 of directly supervises Environmental Monitoring Technicians and 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, cGMPs, and Merck 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/Utilities 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 root cause and require and perform 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
Education Minimum Requirement:
- Bachelors degree in science, engineering, or related areas of study.
Required Experience and Minimum Requirements:
- At least 3 years of prior management/supervisory experience.
- 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 USP Chapters on EM and Utilities and Industry best practices such as PDA white papers
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Visa sponsorship is not available for this position.
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Job: Quality Operations
Employee Status: Regular
Number of Openings: 1
Shift (if applicable):
Company Trade Name: Merck
Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia