Spec, Product Engineering

Posted 16 Jul 2019

St. Louis, Missouri - United States

Req Id 194489

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role:

 

The Product Engineering Specialist is responsible for creating and maintaining production records, specifications and MRP systems for the manufacture of Liquid and Dry Powder Cell Culture Media, Serum, and sterile liquids. The role involves working closely with both internal and external customers and stakeholders to ensure successful product manufacture and ongoing maintenance of the relevant production and quality systems.

 

They will perform the integration of new, modified, transferred, and scaled-up products into site manufacturing processes and systems. Products include all catalog and custom Liquid Media, Dry Powder Media, Serum, ImMEDIAte ADVANTAGE, and sterile solutions.

 

They will build Master Batch Records, Process Instruction Sheets, and other manufacturing documents in the required MRP and electronic document systems. They will create and maintain appropriate routings and other MRP aspects to enable product standard costing and inventory control.  They will liaise with internal stakeholders and customers to develop new specifications for custom Cell Culture Media, serum, and sterile liquid products. 

 

They will provide information to support customer-driven changes to product specification and product attributes for established custom products. They will process change controls to existing specifications and manufacturing documents using MRP and electronic document systems. They will maintain Standard Operating Procedures for the team to ensure all are relevant, up to date, and globally harmonized with other Cell Culture Media sites.  They will serve as a technical resource on the site manufacturing and MRP systems.  They will provide support for product investigations / out of specification results, etc.

 

They may support Design Engineers on specific complex projects as needed to achieve success and meet delivery commitments. They will provide data entry / reporting support to the Global Design Team.  They will collaborate across sites / regions and with the Cell Culture Media Design Program Management function to ensure processes remain harmonized and improvements are employed globally.

 

 

Who You Are:

 

Basic Qualifications

  • Associate degree (or equivalent) in Chemistry, Biological sciences, Engineering, or related field.

Preferred Qualifications:

  • BA/BS in Chemistry, Biological Sciences, or Engineering is desirable.
  • 2+ years industrial experience in custom pharmaceutical, biotech or fine chemical industry. 
  • Demonstrated understanding of manufacturing system s / MRP / Quality systems in a GMP or regulated environment
  • Experience with manufacturing, packaging or testing processes in a GMP environment.
  • Experience with composing professional memos and reports for internal communications
  • Familiarity with Operational Excellence, Lean, and  Six Sigma tools and concepts.
  • Equivalent combination of education and experience Job specific Competencies & Skills
  • Excellent organizational and time management skill s.  Must be able to work under pressure to achieve customer timelines.
  • Self-motivated and able to complete tasks and projects with minimal direction.
  • Practical knowledge of manufacturing systems and GMP / regulated environments
  • Strong interpersonal, written and verbal skills.
  • Understanding of sterile liquid and dry powder manufacturing, packaging, and testing for release to the regulated pharmaceutical and life sciences market.
  • Able to analyze data sets and make technical recommendations based on data and knowledge of scientific and / or manufacturing principles.
  • Practical understanding software tools such as MS Office Suite, MRP systems, electronic document systems
  • Process improvement mindset- able to use Lean and Operational Excellence tools to improve efficiency of the team and streamline processes.

rsremd

 


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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