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:

• Validation Program Development
  
• Periodic Reviews
  
• Risk Assessments
  
• Process Equipment Qualification
  
• Cleaning / Sterilization Validation
  
• Process Validation
  
• Computerized Systems Validation
  

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

Role & Responsibilities:

Critical Mass Consulting, LLC is recruiting a Full Time CQV Engineer to join its San Diego field office. 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 Responsibilities

• 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 in the San Diego 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
• Minimum 2 years of technical experience working in the pharmaceutical, medical device or biotech industry
• Strong understanding of Good Documentation Practices (GDP), and experience working in FDA regulated industries