Life Sciences Technical Consultant

Critical Mass Consulting, LLC; Los Angeles (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Critical Mass Consulting, LLC is seeking a Life Sciences Technical Consultant to join our Los Angeles team. You will develop and execute commissioning/validation protocols and support FDA-regulated projects across client sites in the LA area.

Ideal candidates have 2+ years in pharma/biotech, strong technical writing, GDP knowledge, and familiarity with no-code BI tools. We offer a start-up environment with mentorship and growth opportunities.

Qualifications

• Belief in core values and a culture of collaboration.
• 2+ years of experience in pharmaceutical, medical device or biotech industries.
• Excellent written and verbal communication with strong technical writing skills.
• Strong understanding of GDP and experience in FDA-regulated environments.
• Proficiency with no-code BI tools is a plus (Power BI, Tableau, Looker).

Responsibilities

• Develop and execute commissioning/validation protocols (FAT, SAT, IQ/OQ/PQ) for critical systems.
• Develop and perform risk analyses for validation projects.
• Support multiple client sites on validation projects in the Los Angeles area.
• Help develop internal processes to improve quality of delivery and team engagement.
• Consult clients on commissioning, qualification and validation best practices.
• Develop standards and best practices for development and validation activities.
• Manage medium-small teams and/or projects.
• Participate in team-based projects in Quality Systems and Validation for life sciences clients.
• Establish or maintain quality systems including Change Control, Deviations, and CAPAs.
• Advise clients on latest industry approaches to commissioning, qualification and validation.

Skills

Passion for Life Sciences

Strong communication skills

GDP knowledge

FDA-regulated industry experience

No-code BI tools (Power BI, Tableau, L

Tools

Power BI

Tableau

Looker

Job description

Job Description: Life Sciences Technical Consultant – Los Angeles

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
• Process Engineering
• Quality Management Systems Development
• Validation Program Development
• GMP System Commissioning and Qualification
• Cleaning and 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 Los Angeles, CA 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 Los Angeles 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 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 nice to have (Power BI, Tableau, Looker, etc.)