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Validation Engineer

Orca Bio

Orca Bio

Sacramento, CA, USA
Posted on Wednesday, August 9, 2023
Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
We are looking for Validation Engineers and Senior Validation Engineers reporting to our Director of Engineering. This will be a unique opportunity to work on process, cleaning, computer system, and equipment/utility areas.


  • Provide oversight for Computerized System Validation such as analytical equipment and corporate systems such as electronic QMS systems.
  • In collaboration with QA, sets requirements for the compliant execution of software validation and instrument qualification per regulatory expectations. Builds templates for efficient projects execution and streamline processes as needed.
  • Write, review and approve user requirement specifications, instrument risk assessments, operation, SOPs related to computerized systems for compliance to regulatory requirements.
  • Maintain subject matter expertise and knowledge of industry practices for validation and qualification principles and theories related to computerized systems.
  • Develop computer system compliance strategy, especially for FDA 21 CFR Part11 and Annex 11 compliance.
  • Serve as SME for CSV audits, quality and regulatory audits for computerized systems in conjunction with QA compliance leaders and system owners.
  • Training of personnel performing CSV.
  • Responsible for the timely execution of all systems implementations, software validations and instruments qualifications, in a compliant manner and in alignment with established quality and regulatory requirements.
  • Provides training for regarding systems applications as required.
  • Supports and troubleshoots complex investigations related to computerized systems.
  • Maintains the computerized validation status as part of validation life cycle.
  • Completes periodic reviews on computerized systems per established procedure.
  • Oversees the updates and maintenance of computerized systems on routine basis and evaluates new systems for implementation.


  • BS degree in a scientific or engineering discipline is preferred.
  • Minimum of 3 years’ experience in pharmaceutical cGMP regulated environment, validation and qualification of equipment and computer systems in a pharmaceutical organization.
  • Expert knowledge of CSV, analytical equipment, Master Control, Facility Maintenance System, and QC testing.
  • Thorough knowledge of cGMP, 21CFR Part11 and Annex 11, as well as regulatory guidance related to data integrity.
  • Excellent technical writing, experience in risk assessment, gap analysis, change control and deviation management.
  • Excellent organizational skills and capable of multi-tasking.
  • Ability to work independently with minimum supervision.
Who we are
We are scientists, engineers and business operators working with urgency to develop new therapies for patients faced with no or extremely limited options today.
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all patients who need them.
We strive to do things right. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not”, and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
We invite you to join us and bring your unique perspective and experiences to our team.