Associate Director Aseptic Process Support:
Merck

MAN004672-en_US
Merck
Elkhorn Nebraska
Pharmaceutical
Description
Requisition ID: MAN004672

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 Associate Director Aseptic Process Support position supports our Animal Health Manufacturing locations within the United States and Globally.  The primary work location for this position can be at one of our United States manufacturing locations: Ames, Iowa; Desoto, Kansas; Elkhorn, Nebraska; Millsboro, Delaware; or Worthington, Minnesota.

 

The Aseptic Process Support (APS) group within the Global Technical Operations organization of the our Manufacturing Division Animal Health (MAH) is responsible for harmonization and standardization of the execution of aseptic processes. To that end the Aseptic Processes Support group supports the sites within our Manufacturing Division Animal Health network with site and equipment design, validation of utilities, equipment and processes and supports the sites with execution of aseptic manufacturing processes and routine checks (like media simulations).


The Aspectic Process Support wil provide a set of sites support with design, classification, validation, and maintenance of site, equipment and processes in a status allowing aseptic process execution according to relevant cGMP regulations. 


This role will provide direction and training to a set of sites within the network regarding sterile facility and equipment design, classification, validation and maintenance. In addition you are part of the team that supports the execution of Risk Assessments and Failure Mode and Effect Analyses as well as Root cause investigations in case of events. In the network you act as a global aseptic process subject matter expert and provide hands on implementation support to sites as required.


Primary activities include, but are not limited to:


Providing tactical leadership in the development, implementation and maintenance of aseptic practices within the MAH sites falling under your responsibility.


  • Establishing and directing implementation of proactive measures across the MAH sites falling under your responsibility.
  • Partner with MAH and MMD Human Health communities to ensure compliance to internal standards and regulatory guidelines
  • Provide support for Aseptic Process Simulations and Sterility failure investigations
  • Provide support in creation and implementation of Aseptic Process related Policies and Standards.
  • Raising, as APS team member, the level of awareness, understanding and execution of Aseptic Techniques across the MAH network.
The Aseptic Process Support group operates on a global level and supports our manufacturing organizations globally. The preferred location for this position is any US MAH manufacturing site. The role will involve a significant amount of travelling to other MAH sites to provide the support requested. Travelling can reach the level of 25-50% of the working time.

Qualifications


Education:

  • Bachelor of Science in Biology, Pharmacy,OR Process engineering.
Required :
  • Miniumum of Five years of experience in Pharmaceutical or Biotech Industry (sterile manufacturing of pharmaceutical or biological components / finished products)
  • Demonstrated Microbiological knowledge and practical experience for minium of 5 years in pharmaceutical area
  • You are competent in analyzing complex sterile manufacturing situations and show practical problem solving capabilities. 
  • You are fluent in written and verbal English language. In addition the candidate is proficient in technical writing and reporting sterility assurance investigations, root cause investigations). In addition experience in writing of globally used technical instructions and procedures.
  • You have demonstrated interpersonal skills (leadership, coaching, development, performance management, and communication skills) 
Preferred :

  • In addition MSD is looking for enthusiastic support employees who are accurate, result driven and have a quality compliance mindset. You act as an example and you are a driven team player.

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. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.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:

 

            EEOC Poster

            EEOC GINA Supplement 



AHMAN2017, HJ012018



Job: Manuf./Operations Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement