Life Sciences Technical Consultant

3 weeks ago


Portland, United States Critical Mass Consulting Full time
Job DescriptionJob DescriptionSalary:

Critical Mass Consulting, LLC is seeking individuals who want to learn and develop within a dynamic, start-up environment.  We believe in our purpose: To develop a company which thrives on connectivity and engagement; to build a premier consulting organization, which rewards creativity, contribution, and growth.


Critical Mass Consulting, LLC is supporting Life Sciences clients in the areas of:

  • Project Management
  • Validation Program Development
  • Process Equipment Qualification
  • Cleaning / Sterilization Validation
  • Process Validation
  • Computerized System Validation (CSV)


Our company places an emphasis on continuous personal development.  This includes support/financing of technical training, mentorship, and development of high performance teams.


Job Description:

Critical Mass Consulting, LLC is recruiting Consultants to join its Portland, OR field area. If you have a passion for Life Sciences and helping others, we are interested in discussing our company, our process and what it means to join our team-focused organization.


Expected Activities

  • Develop and execute commissioning/validation protocols, such as factory and site acceptance test (FAT, SAT), installation, operational and performance qualifications (IQ/OQ/PQ) on various critical systems, process equipment and supporting processes.
  • Develop and perform Risk Analyses
  • Support multiple client sites on validation projects throughout the Portland area
  • Work on developing internal processes to increase quality of delivery, and increase team engagement
  • Consult clients on latest industry approaches to commissioning, qualification and validation
  • Develop standards and best practices for development and validation activities
  • Manage medium-small teams and/or projects


Additional Responsibilities

Participate in team-based projects, supporting life sciences clients in the areas of Quality Systems and Validation

  • Establish or maintain quality systems, including Change Control, Deviations, and CAPAs programs
  • Consult clients on latest industry approaches to commissioning, qualification and validation


Required Qualifications:

  • Belief in our Core Values.  These 4 values provide the foundation for how we operate as a company.  With these common shared values, we can effectively accomplish our mission of organizational excellence.
    • People Come First
    • We Build Together
    • Empowering Growth and Leading People to Make a Difference
    • Joy and Discipline, Life in Balance
  • Strong interest in Life Sciences and a passion for helping others
  • Excellent written and verbal communication skills, emphasizing strong technical writing skills
  • Pass the Transportation Security Administration (TSA) Security Threat Assessment (STA)
  • Minimum 2 years of experience working in the pharmaceutical, medical device or biotech industry
  • Strong understanding of Good Documentation Practices (GDP), and experience working in FDA regulated industries
  • Proficiency in no-code business intelligence tools is a plus (Power BI, Tableau, etc.)

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