Senior GMP Data Systems Engineer
Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.
We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma – Your Body. Your Hope. Your Cure.
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.
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
- Proficiency with SampleManager or other commercial QC LIMS platforms, particularly regarding configuration & administration
- Experience with manufacturing data platforms (MES, SCADA, Historian, etc)
Salary Range: $115,600 - $149,600
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a competitive unlimited Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.