LIMS Data System Engineer

Posted 29 Mar 2019

St. Louis, Missouri - United States

Req Id 190020

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 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. EMD Performance Materials is a business of Merck KGaA, Darmstadt, Germany.
 


Your Role:

Cherokee Quality Control in St. Louis, MO, supports manufacturing of custom products including active pharmaceutical ingredients, excipients, and raw materials used within the health care industry.

This position within the GMP Quality Control department is responsible to support the development, validation, implementation and ongoing administrator support of a LIMS (Laboratory Information Management System) and other data systems. 

 

ESSENTIAL JOB FUNCTIONS

  • Support the development, validation and implementation of a LIMS for a GMP laboratory.
  • Draft and review policy, procedures and protocols as assigned.
  • Execution and/or review of scripts and test data associated with the validation of various software systems in the GMP laboratory.
  • Work in accordance with current GMPs and GAMP requirements.
  • Lead technical troubleshooting of data systems.
  • Lead process improvements to improve laboratory performance.
  • Prepare technical reports as assigned.
  • Manage project milestones for internal and external customers to ensure on quality and on time success.
  • Additional duties as assigned by QC Management.

Who You Are:

The ideal candidate has a broad range of experience with the validation, implementation and maintenance of various computer software systems in a GMP laboratory.

Basic Qualifications:

  • BS/BA in a related life science or computer science field
  • Strong understanding of GMP guidance and regulations for APIs, excipients and drug products
  • Strong understanding of data integrity requirements, including the review of electronic audit trails
  • Strong technical writing, root cause analysis and scientific reasoning
  • Experience in lean lab practices and continuous improvement initiatives

Preferred Qualifications:

  • MS degree in a related life science or computer science field
  • 5+ years of GMP experience in pharmaceutical, biopharmaceutical or similar industry
  • 3+ years of GMP administration experience in LIMS, database, and/or CDS (Chromatography Data System)
  • GMP experience with validation and the change control associated with validated computerized systems
  • GMP experience with ELN (Electronic Lab Notebooks)
  • Chemical environment- Must be able to perform tasks while wearing personal protective environment

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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