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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Quality Operations Environmental Monitoring Process Steward works within quality and with other teams to manage environmental monitoring for finished antibiotic processing, bulk sterile API processing and vaccine/therapeutic protein processing. This position is within the environmental monitoring program for the site and is responsible for cGMP compliance, review of data, atypical resolution with production, trend analysis, cost and time reduction initiatives, training, audits, and troubleshooting. In addition, it is possible this position will also work with global Merck Network as a representative of the site on Environmental Monitoring related topics.
Qualifications: Education Minimum Requirement:
- Ensure that microbiological environmental monitoring and analysis is performed according to Divisional Guidelines and adheres to all applicable regulatory requirements. Program includes surface, air, personnel, and cleaning.
- Extensive involvement in internal and external regulatory audits.
- Responsible for training and development of site staff as well as documentation and corrective actions related to deviations and excursions.
- Assists production as technical expert related to requirements for testing of classified areas and microbial growth within the area.
- Routinely evaluates the trends of microbial counts and growth, prepares written environmental microbial data summaries as required
- Initiates ,leads, and or approves environmental monitoring investigations to evaluate personnel gowning practices, equipment cleanliness/sanitization, and cleaning operations including physical construction of the room and performance of the HVAC system.
- Ensure that the reporting of data and maintenance of records is performed as per Division Guidelines. Also, that the interpretation of the data is correct and that the results are effectively communicated to appropriate individuals/workgroups.
- Site expert on Disinfectant Efficacy, able to guide production areas on appropriate cleaning in relation to the study and the effects on the microbial flora of the site.
- Quality Management System (QMS) Sub-System Owner for applicable Chapters.
Required Experience and Skills:
- Bachelor's degree required, concentrations in microbiology or biology (must have microbiology coursework)
Preferred Experience and Skills:
- Position requires technical knowledge of microbial physiology, and microbial flora common to pharmaceutical industry
- Position requires technical knowledge related to environmental monitoring, sterilization methods, disinfection/sanitization methods, current good manufacturing practices and an understanding of aseptic handling procedures.
- Requires knowledge of Microsoft excel, power point and word.
- Requires good written and verbal communication skills.
- Requires strong leadership ability with public speaking skills.
- Minimum of 5-year experience in aseptic production processes or minimum of 5-years- Medical Technology with experiences in Microbiology, required
- Familiar with CFR, cGMP, ISO, USP/NF, EP and JP regulations
- Creates and nurtures practical networks that foster teamwork and empowerment to strategically manage Environmental Monitoring requirements
- Provides input and suggestions for improving microbiological control in the facility
- Communicates information clearly, simply and in a timely manner. Good written and spoken English required.
- Demonstrates the ability to apply continuous improvement tools to affect positive change
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com .
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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