Senior Specialist Engineering - Technical Operations, External Manufacturing Sterile Drug Product
Location:
West Point , Pennsylvania
Posted:
January 05, 2017
Reference:
PRO015100
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 individual will ensure project timelines are met while executing technical transfers to and from External Partners (EP's). Responsibilities will also include leading the technical interface with the external partners in the area of process support to aid in the resolution of production issues that could impact Supply and also to provide guidance on process optimization. The incumbent must have strong technical knowledge of sterile formulation and filling unit operations. The individual will also possess strong business acumen and interpersonal skills.

Activities will include but not limited to:
  • Reports to Associate Director or Director, External Manufacturing Sterile, and receives general direction on goals and objectives. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues.
  • Executes technical transfers, provides on-going support to External Partners to resolve manufacturing issues, and develops plans to meet capacity needs.
  • Collaborates with Purchasing, Relationship Manager, Quality, Regulatory and others to evaluate External Partners for inclusion in the MSD Network.
  • Executes technical due diligence assessments at EP's.
  • In concert with Commercialization, Quality, and Regulatory, ensures that EP's are inspection ready for all new product introductions and transfers.
  • Develops and executes validation strategies for new and existing products.
  • Provides a single point of technical contact to assigned EP's, impacted Manufacturing Division sites and Commercialization.
  • Provides expert consultation and review of sterile processing technical matters.
  • Provides a 'calibrated' technical review of EP process change requests, atypicals, and Master Batch Record changes.
  • Understands the true regulatory requirements and partners with Operations, Quality, and the EP to develop more efficient ways to meet these requirements.
  • Based on calibrated oversight model, minimizes duplication of efforts between EP and MSD systems
  • Partners with EP's to achieve business goals and to establish a common culture that benefits both Merck and EP.



Qualifications:
Education:
  • Required: BS in chemical/biochemical engineering, pharmaceutical science or chemistry/biology

Required:
  • Minimum of 5 years manufacturing experience in the areas of sterile process start up and technical transfer or have demonstrated experience in these areas
  • Travel will be a requirement of this position at approximately 25%
  • Must be able to multi-task and work within tight deadlines.
  • This position requires flexibility and the ability to work independently, as well as excellent organizational skills.
  • Strong professional and interpersonal communication skills are also required.

Preferred:
  • In addition to a good working knowledge of English, fluency in other languages is a plus.
  • Project Management and Basic Statistical Analysis experience are preferred


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 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:

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