Aseptic Process Support Senior Specialist Job - United States
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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.
This position will serve to raise the level of Aseptic Robustness across US Midwest region in areas of identified weakness including Technology, Operator Training, Engineering Design, Single use disposables, Qualification, Cleaning disinfection, gowning EM programs, etc.
The Aseptic Process Support Specialist is responsible for:
- Providing tactical leadership in the development, implementation, and maintenance of aseptic practices within the Animal Health network
- Establish and direct deployment/implementation of proactive measures across MMD Animal Health Sterile facilities to enhance and sustain aseptic programs
- Ensure compliance to internal standards and regulatory guidelines
- Develop and Lead with other AD’s the Sterile Community 'Forum' within the Animal Health network
- Provide Media Simulation and Sterility Failures Investigation support
- Provide hands on support in implementation of Aseptic Processing Policies and Standards
Education Minimum Requirement:
- Bachelor of Science degree in Microbiology or related discipline
Required Experience and Skills:
- Minimum 10 years experience in Manufacturing, working in sterile environments with background in microbiology and sterile process equipment design.
- Extensive hands on experience in the development of aseptic programs include media simulation, smoke studies, Clean Room Qualification, Steam-in-Place validation, Environmental Monitoring, etc.
- Incumbent must possess strong analytical, problem solving, and technical writing skills required to provide Quality, microbiological and technical expertise for sterility assurance investigations related to media challenge/sterility failures, product deviations, and contamination control.
- Must also possess demonstrated interpersonal skills, including leadership, coaching and development, performance management, motivation, communications and negotiations.
Preferred Experience and Skills:
- Use of Six Sigma and Lean Six Sigma tools
- Green or Black Belt certification strongly desired
- Pharmaceutical Experience in an operations or aseptic technical support leadership position
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.
For more information about personal rights under Equal Employment Opportunity, visit:
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality GMP Related
Job Title:Sr. Spclst, Quality Systems & Compliance
Primary Location: NA-US-MN-Worthington
Other Locations: NA-US-KS-DeSoto, NA-US-NE-Elkhorn, NA-US-IA-Ames
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Worthington
Job Segment: Microbiology, Law, Engineer, Pharmaceutical, Lean Six Sigma, Science, Legal, Engineering, Management