Senior GMP Data Systems Engineer

POSITION SUMMARY

As a member of the Informatics team, the GMP (Good Manufacturing Practices) Data Systems Engineer will play a critical role in enhancing the capabilities of our new GMP manufacturing facility while also ensuring the integrity, reliability, and compliance of our Data Systems in accordance with GMP requirements. This position will involve working closely with many cross-functional teams, primarily in our Colorado manufacturing facility, to build out, enhance, and maintain our GMP systems thereby enabling data-driven decision-making and quality and efficiency in our processes.  We're looking for an experienced GMP Systems Analyst or Engineer with high aptitude, energy, and drive to keep our newly implemented GMP Data Systems delivering high value and data integrity as we grow.

REQUIREMENTS 

Specific responsibilities include:  

• Technical System Ownership:
  • Maintain/administer/enhance our newly implemented GMP QC (Quality Control) LIMS (Laboratory Information Management) system
  • Support build & implementation of new phases of QC LIMS development in line with the growing business needs
  • Ensure GMP-compliant Data Systems are maintained, validated, and operate reliably.
  • Support build, implementation, validation and change-control efforts for current and future systems.
  • Engage and oversee 3rd party vendors as required to ensure successful delivery and support of systems
• Troubleshooting and Issue Resolution:
  • Investigate and resolve data system issues, providing timely support to end-users and collaborating with IT teams as needed.
• Data Integrity Assurance:
  • Maintain controls to ensure data integrity, including access controls, data backups, and audit trails.
• Documentation and Reporting:
  • Generate and maintain accurate and up-to-date documentation related to Data Systems, including SOPs (standard operating procedures) & periodic reviews.
  • Prepare regular reports and metrics related to data system performance and compliance.
• Continuous Improvement:
  • Identify opportunities to enhance data system efficiency, reliability, and compliance, and implement necessary changes in collaboration with relevant stakeholders.
• Training and Development:
  • Provide training and guidance to end-users on the proper use of Data Systems and GMP compliance requirements.

The successful candidate will have:

• Minimum Bachelor's degree in science, engineering, mathematics or similar disciplines plus 5 years experience with Data Systems in a GMP Biotechnology/Pharmaceutical environment. Equivalent combination of education and experience will be considered.
• Experience working in or administering GMP LIMS systems in BioPharma environment
• Operational experience within GMP computerized system validation & change control processes
• Strong interpersonal skills to operate as a Business Partner to GMP data-generating teams

Preferred Qualifications:  

• Proficiency with SampleManager or other commercial QC LIMS platforms, particularly regarding configuration & administration
• Experience with manufacturing data platforms (MES, SCADA, Historian, etc)

Physical Requirements:  

• N/A

Salary Range: $115,600 - $149,600