Senior Validation Engineer

Umoja Biopharma; Louisville (KY); On-site; USD 88,000 - 110,000; Full time

Job summary

Join a pioneering biotech start-up dedicated to transforming cancer treatment. As a Senior Validation Engineer, you'll play a crucial role in ensuring the quality and compliance of cutting-edge therapies. Collaborate with a diverse team to execute validation activities, author critical documents, and drive continuous improvement initiatives. This is an exciting opportunity to contribute to groundbreaking science while working in a state-of-the-art facility. If you're passionate about innovation and making a difference in patients' lives, this role is for you!

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401k with Match

Paid Time Off

Commuter Benefits

Cell Phone Stipend

Qualifications

• 5+ years of validation-related experience in a cGMP manufacturing environment.
• Experience authoring validation lifecycle documents and test protocols.

Responsibilities

• Develop and execute CQV activities for GMP equipment and computerized systems.
• Lead and execute periodic review and revalidation programs.

Skills

Validation Lifecycle Management

CQV Principles

Project Management

Cross-Functional Collaboration

Data Integrity

Education

Bachelor’s degree in Engineering or related scientific field

Tools

LIMS

ERP

CMMS

BMS/EMS

Job description

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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.
  
  

The Successful Candidate Will Have

• Bachelor’s degree in engineering or related scientific field and 5+ years of validation-related experience in a cGMP manufacturing environment.
• Previous experience in a cGMP biopharmaceutical manufacturing and/or testing facility startup and/or operations environment.
• An unwavering dedication to Umoja’s purpose through a team-centric and solutions-obsessed approach.
• Ability to think and lead conceptually and strategically, arriving at practical and pragmatic conclusions.
• Proficient project management and leadership skills.
• Ability to effectively collaborate, and lead validation initiatives, across multiple functional areas.
• Comprehensive understanding and knowledge of CQV principles, requirements, and practical application in support of GxP clinical phase operations.
• Experience in the application of CQV principles and requirements to facility & utility systems, equipment, instruments, and computerized systems commonly used in a GxP environment (e.g., building utility systems, manufacturing and laboratory equipment and instruments, LIMS, ERP, CMMS, BMS/EMS, etc.).
• Experience authoring validation lifecycle documents, test protocols.
• Experience executing validation protocols, including equipment IQ/OQ/PQ protocols and computerized system validation protocols.
• Understanding of data integrity and computerized system quality assurance principles, including risk-based, practical application.
• Adaptability to changes in project and workplace priorities and ability to operate under ambiguous circumstances with flexibility.
• Work independently with risk-based decision-making capability.
• Strong commitment to establishing and maturing a diverse and inclusive working environment.
• Commitment to following safety protocols and work practices.
  
  

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
  
  

Salary Range: $88,825 - $109,725

Benefits Offerings

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 4% deferral. Umoja also provides a generous 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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