Life Sciences Technical Consultant - Portland, OR

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.)