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.

Job Description:

Critical Mass Consulting, LLC is recruiting Validation Engineers 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.

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

- CSV

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

Responsibilities

Participate in team-based projects, supporting life sciences clients in the areas of Cleaning Validation, Equipment qualification, Process Validation, Computerized systems validation, Facilities and Utilities qualification

-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

-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

Prerequisites:

-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

-2 or more years of experience in the areas of commissioning, qualification, validation

-2 years of cleaning validation experience is a plus

-Strong interest in Life Sciences and a passion for helping others.

-Strong written and verbal communication skills, emphasizing strong technical writing skills.

-Proficient in Microsoft Office Suite (MS Word and MS Excel)

Preferred Experience:

-2 or more years of experience in engineering/validation field in pharmaceutical, medical device or biotech industry.

-Strong understanding of Good Documentation Practices (GDP), and experience working in FDA regulated industries.