Associate Director, S&V CoE, Global Sterile Site Support 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.
The incumbent will be part of the Global Sterile Site Support group of the GTO-Sterile & Validation COE. This group provides expert level Tech Ops support to Merck's sterile manufacturing sites (both internal and external). The incumbent will report into the Leader GSSS
•Serving as a steriles technical subject matter expert applying advanced theory, technical principles and expert judgment in providing sterile technology support to Merck’s internal and external sites.
•Point-of-Contact for the GTO-Sterile&Validation COE for a number of sterile sites and as such responsible for the relationship with and support for these sites.
•Assisting the Network in troubleshooting complex sterile processing, equipment and product problems through critical analytical thinking and a "hands-dirty" approach.
•Identifying best practices in sterile technology and sharing these with the sterile sites.
•Development of standard processes and standard tools for e.g. critical sterile investigations
•Leading and/or participating in critical investigations and/or process improvement initiatives to improve product quality, robustness and process capability for internal and external form/fill sites.
•Providing sterile technical assistance for quality and regulatory activities including site inspections and preparation of technical documents.
•Engaging externally to bench mark and influence industry best practices.
•Keeping abreast of discoveries in the field to ensure that Merck remains an industry leader in sterile technology.
•Completing all activities with the highest regard for all Merck divisional policies and local site procedures for safety, quality and regulatory compliance.
Education Minimum Requirement:
•BS in Engineering, Pharmaceutical Sciences, Microbiology or other Sciences
Required Experience and Skills:
•At least 8 years in sterile manufacturing or technical support roles.
•Demonstrated leadership and teamwork skills; demonstrated technical contributions.
•Strong communications, planning and collaboration/negotiation skills.
•Ability and willingness to travel to the sterile sites in USA, Europe, Latin America and /or Asia for up to 25% of the time, including on-site support for prolonged periods of time (e.g. two weeks on-site – one week remote support – two weeks on site, etc.).
Preferred Experience and Skills:
•Preferred MS or PhD in Engineering, Pharmaceutical Sciences or Microbiology.
•Lean or Six Sigma Green Belt or Black Belt certification.
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 firstname.lastname@example.org.
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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: Engineering Generic
Job Title:Assoc. Dir, Engineering
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-VA-Elkton, NA-US-NC-Durham
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Hazardous Materials: No
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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