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LIMS Data System Engineer

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works, and plays through next-generation advancements in healthcare, life science, and electronics. 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.

 

This role does not offer sponsorship for work authorization.  External applicants must be eligible to work in the US.

 

Your Role: 

This position is first shift in Verona, WI.  Verona/Madison Quality Control supports manufacturing of active pharmaceutical ingredients. 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. 

 

  • Support the development, validation, and implementation of a LIMS for a GMP laboratory.
  • Draft and review policy, procedures, and protocols as assigned.
  • Author, execute, and/or review of scripts and test data associated with the validation of various software systems in the GMP laboratory.
  • 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.
  • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.  
  • Exercise judgment within generally defined procedures and practices to select techniques for obtaining solutions.
  • Solve problems and make decisions with assistance.
  • Perform preliminary review of analytical data for accuracy and quality.
  • Maintain projects and timelines with minimal oversight.
  • Participate in OOS and OOT investigations via testing and good documentation. 
  • Apply good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor.
  • Work cooperatively within the QC department and with other departments to achieve project goals.
  • Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicable
  • Work in a safe manner and maintain the cleanliness of the work environment.
  • Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.
  • Additional duties as assigned by QC Management.

 

 

Physical Attributes:

  • Work in a chemical environment
  • Ability to perform tasks while wearing personal protective equipment (chemical protective clothing) for extended periods of time
  • Occasionally lift and/or move up to 25 pounds unassisted and push and pull heavy materials to complete assignments.  May lift more poundage with assistance. 
  • Utilize speaking and hearing.

 

Who You Are:

 

Minimum Qualifications:

  • Bachelors degree in Chemistry, Biology, Biochemistry OR another biological sciences discipline.
  • 2+ years in a GLP or cGMP analytical laboratory environment.

 

Preferred Qualifications:

  • MS degree in a related life science or computer science field
  • Experience with the validation, implementation, and maintenance of various computer software systems in a GMP laboratory
  • GMP experience in pharmaceutical, biopharmaceutical, or similar industry
  • 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
  • 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

 

RSRMS

 

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.

 

Job Requisition ID:  214609
Location:  Verona
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Biochemistry, Database, Pharmaceutical, Computer Science, Laboratory, Science, Technology

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