CQV Engineer

Critical Mass Consulting, LLC; San Diego (CA); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Support for technical training

Mentorship

Development of high-performance teams

Résumé du poste

A consulting firm in San Diego seeks a Full Time CQV Engineer passionate about Life Sciences. Successful candidates will develop and execute validation protocols, manage projects, and consult clients on industry best practices. Required qualifications include a strong interest in Life Sciences and at least 2 years of experience in regulated industries. The role emphasizes team collaboration and continuous personal development.

Qualifications

• Minimum 2 years of technical experience in pharmaceutical, medical device, or biotech industry.
• Experience in FDA regulated industries.

Responsabilités

• Develop and execute commissioning/validation protocols on critical systems.
• Support multiple client sites on validation projects.
• Manage medium-small teams and/or projects.

Connaissances

Strong interest in Life Sciences

Excellent communication skills

Strong technical writing skills

Understanding of Good Documentation Practices (GDP)

Description du poste

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
• Process Equipment Qualification
• 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