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.

POSITION SUMMARY

Umoja Biopharma is seeking a Senior Validation Engineer to support on-going cGMP manufacturing, new equipment/system qualification, periodic review, revalidation, continuous improvement initiatives, and future project execution at Umoja’s Colorado Laboratory & Innovative Manufacturing Building (The CLIMB) in Louisville, CO. The primary responsibility of this position will be to serve as the validation subject matter expert (SME) at The CLIMB, with primary focus being on planning and execution of system qualification/validation, strategic program maturation, and cross-functional collaboration on new projects, products, or processes.
This individual must demonstrate effective collaboration, clear communication, and a proven ability to operate independently.
This position will be based in Louisville, CO.

CORE ACCOUNTABILITIES

Specific responsibilities include:

• Collaborating with management to develop, plan, and successfully execute CQV activities for GMP equipment, instruments, utilities, and computerized systems.
• Authoring, reviewing, and approving validation lifecycle documents, such as master plans, procedures, protocols, reports, and other GMP documents as a validation SME.
• Executing validation testing, including both equipment/instrument IQ/OQ/PQ protocols and computerized system validation test protocols.
• Coordinating cross-functionally to ensure alignment of requirements and validation strategy.
• Leading and executing the periodic review and revalidation program.
• Identifying and assisting in the management and execution of change controls to ensure equipment and systems remain in a qualified state.
• Facilitating and guiding resolution of discrepancies, roadblocks, and obstacles related to CQV activities in a timely manner through effective collaboration and communication with appropriate stakeholders.
• Identifying and proposing areas for operational and validation program improvement, facilitating implementation where appropriate.
• Participating in the design and specification of new equipment/systems.
• Ensuring computerized systems meet required data integrity requirements, as verified during design and qualification.
• Tracking contractor spend in relation to expected deliverable completion.

PREFERRED QUALIFICATIONS:

• Previous experience implementing or maturing CQV programs in a clinical phase GxP startup environment, preferably in support of cell/gene therapies.
• Previous experience transitioning CQV programs from supporting clinical phase operations to supporting readiness for commercial activities.
• Experience with continuous improvement initiatives and tools
• Experience with media fill/aseptic process simulation testing/strategy.
• Experience with analytical equipment/systems and single use processes/equipment.

PHYSICAL REQUIREMENTS:

• Ability to wear personal protective equipment including gloves, protective clothing, and eye safety glasses.
• Ability to perform physical tasks including standing, use of hands, walking, bending, kneeling, and occasionally moving materials up to 30 pounds.
• Ability to primarily work onsite, working remotely when appropriate

• Collaborating with management to develop, plan, and successfully execute CQV activities for GMP equipment, instruments, utilities, and computerized systems.
• Authoring, reviewing, and approving validation lifecycle documents, such as master plans, procedures, protocols, reports, and other GMP documents as a validation SME.
• Executing validation testing, including both equipment/instrument IQ/OQ/PQ protocols and computerized system validation test protocols.
• Coordinating cross-functionally to ensure alignment of requirements and validation strategy.
• Leading and executing the periodic review and revalidation program.
• Identifying and assisting in the management and execution of change controls to ensure equipment and systems remain in a qualified state.
• Facilitating and guiding resolution of discrepancies, roadblocks, and obstacles related to CQV activities in a timely manner through effective collaboration and communication with appropriate stakeholders.
• Identifying and proposing areas for operational and validation program improvement, facilitating implementation where appropriate.
• Participating in the design and specification of new equipment/systems.
• Ensuring computerized systems meet required data integrity requirements, as verified during design and qualification.
• Tracking contractor spend in relation to expected deliverable completion