Aseptic Process Reliability Engineering, Sr Specialist Job - United States
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 supports manufacturing operations by providing training on best aseptic practices, environmental programs andCIP/SIP systems. Also support for cleaning and disinfection programs as well as facility design and qualification. The role will conduct risk based analysis on aseptic systems and also lead sterility failure investigations, therefore must have good problem-solving skills.
Education Minimum Requirement:
- Bachelor of Science degree in microbiology, engineering or a related discipline
Required Experience and Skills:
- Minimum 10 years experience in Manufacturing working in sterile environments with background in engineering, sterile process equipment design, and sterile facility design.
- Extensive hands-on experience in executing facility and equipment train risk assessments including smoke studies, Clean Room Qualification, Cleaning-in-Place and Steam-in-Place validation, Environmental Monitoring, etc
- Incumbent must possess strong analytical, problem solving, and technical writing skills required to provide Quality and Technical expertise for sterility assurance investigations related to media simulation or/sterility failures, product deviations, equipment failure, filter validation, and contamination control.
- Must also possess demonstrated interpersonal skills, including leadership, coaching and development, performance management, motivation, communications and negotiation.
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, technical or maintenance 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.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Process Engineering
Job Title:Sr. Spclst, Engineering
Primary Location: NA-US-KS-DeSoto
Other Locations: NA-US-MN-Worthington, 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
Job Segment: Microbiology, Process Engineer, Engineer, Pharmaceutical, Lean Six Sigma, Science, Engineering, Management