LIMS Data System Engineer hos Merck Aktiebolag

Udløber om 11 dage

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

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