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Computer Systems Validation Lead

Company: Umoja Biopharma
Location: Boulder
Posted on: November 12, 2021

Job Description:

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Boulder, 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 Boulder, 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 SummaryUmoja Biopharma is looking for a CSV Lead with experience in plant start-up, operation and maintenance of a GMP / GxP systems ensuring systems are validated and are maintained in a qualified state. The holder of the position acts as the owner of all computer system validations and acts as a link between departments, functions and contractors. This person serves as a technical resource for the entire manufacturing, QC, MSAT and PD departments and provide expertise and supportive data for operational reviews.This position will be based in Louisville, CO.
Specific responsibilities include:

  • Leads the CSV efforts at Umoja sites by collaborating with Capital Engineering project leads and system stakeholders (IT, Facilities, Quality, Manufacturing, EH&S, PD, MSAT, QC) on the commissioning and start-up of a biotechnology facility and programs that support GMP / GxP systems in the development and commercialization of products.
  • Collaboratively develops a Computer System Lifecycle for GMP / GxP systems.
  • Development and review of computer validation documentation (i.e., Validation Plan, URS, FRS, IQ, OQ, PQ, RTM, summary report).
  • Drive/participate in meetings to with key stakeholders and provide key inputs in the validation process and the definition of deliverables.
  • Acts as the Quality contact and Subject Matter Expert (SME) for activities related to validation and Quality Risk Management for assigned GMP / GxP computer systems.
  • Assists and/or performs quality reviews and Quality Assurance (QA) vendor audits related to computer systems.
  • May assist in the management and/or oversight of other external resources for CSV-related activities.
  • Performs GMP / GxP-related activities in alignment with business requirements and ensures that they meet compliance standards as defined by the applicable regulations.
  • Ensures evolving validation requirements are appropriately applied to Umoja's CSV activities.
  • May write, contribute to or edit, as appropriate, SOPs related to the validation of GMP / GxP computer systems and/or the use or administration of the validated system(s).
  • May assist in the development of training materials, related to the validation of GMP / GxP computer systems and/or the use or administration of validated systems. Works closely with IT and software/system vendor(s) as needed, to ensure user/design materials and test documentation can be leveraged and is acceptable.
  • Applies knowledge of Cloud-based, SaaS systems, thoroughly interprets CSV regulations, guidelines and GMP / GxP practices and meets regulatory compliance and corporate business requirements.
  • Liaises with IT and other cross-functional business teams in the development of GMP / GxP/Non-GMP / GxP deliverables, SOPs, Work Instructions, Policies and other critical documentation.
  • Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGMP / GXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.
  • Thorough understanding of risk based validation for computerized systems, industry standards and best practices for computer system validation, such as GAMP 5.
  • Be flexible and adaptable to changes in project and work place priorities
  • Ensure high safety standards within the areas of responsibility are considered and adhered to as governed by local, state and federal regulations, laws and policies as well as Umoja's policies and directives
  • Collaborate and coordinate internal and external resources to support project needs.
    --- The successful candidate will have:
    • BS in a Computer Science or Engineering field or equivalent experience
    • 5-8 years experience with GMP / GxP Computer System Validation, specifically in pharma / biotechnology manufacturing systems and lab systems
    • Supervision of protocols execution activities
    • Experience managing vendors / contractors
    • Excellent communication skills
    • Able to manage direct relation with stakeholders and project team members
    • Experience working in a matrix environment.
    • Enjoys working in a diverse and inclusive environment.
    • Experience in cGMP cell or gene therapy manufacturing and/or testing facility is a plus
    • Experience with regulators is a plus.

Keywords: Umoja Biopharma, Boulder , Computer Systems Validation Lead, IT / Software / Systems , Boulder, Colorado

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