Validation Engineer
Commissioning Agents, Inc. - San Diego, CA

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Who We Are

Commissioning Agents, Inc. (CAI) is a rapidly expanding, 300+-person professional services organization working across the globe to create change in the industries in which we work. As a member of our team you will work at the leading edge of the pharmaceutical, biotechnology, medical device, nutritional, power generation, and building commissioning industries to advance knowledge and provide industry best-practices to our clients. While our headquarters is located in the United States, we have offices in Puerto Rico, the United Kingdom, Ireland, Singapore and China.
CAI has developed a program of skill and knowledge based qualification and a continuing education program that includes industry conferences, training courses, vendor training courses and internal training to increase our employees ability to deliver industry-leading services. Our focus on professional development enhances staff confidence, allows our employees to work capably on a wider variety of project assignments, and increases job and personal satisfaction.

We are 100% employee-owned through an Employee Stock Ownership Program (ESOP). All of our employees are full-time, benefited, W-2 employees.

Please take this opportunity to learn about Commissioning Agents, where we believe that our employees are our most important asset and are dedicated to creating and maintaining a great place to work.

The Position

1. Manages and executes the qualification and validation of manufacturing equipment, infrastructure (i.e., utilities and support systems) and software to assure quality and stability prior to deployment in production environments.
2. Ensures that applicable regulations, guidelines and company procedures are followed and applied during all stages of project activities.
3. Creates qualification and validation deliverables, such as validation project plans, system impact assessments, criticality assessments, risk assessments, validation (e.g., DQ, IQ, OQ, and PQ) protocols, commissioning plans and test scripts, commissioning and validation summary reports, etc., for new functionality, enhancements or changes, maintenance releases, and/or periodic revalidation.
4. Works with cross-functional teams (e.g., Operations, Technology, Quality Assurance, and Project Managers) to evaluate and set testing milestone criteria and milestones to ensure projects are on schedule and meet quality compliance requirements.
5. Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, and executing qualification protocols or validation project plan (i.e., field execution, sample collection, etc.).
6. Supports risk assessment and control activities.
7. Provides training and mentoring related to all aspects of the job to new team members.
8. Assists in resolving and documenting technical and project-related issues.

Who You Are

  • Five+ years of qualification and/or validation experience in a regulated environment.
  • Experience in biotech, pharma, and/or medical device is preferred.
  • Additional experience in cleaning validation, process validation, and/or method validation is a plus.
  • Strong technical writing, verbal communication, interpersonal and problem solving skills.
  • Proficient in validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
  • Expertise in interpretation of applicable regulations and industry guidance documents used in cGMP/GXP environments (e.g., CFRs, ICH, ISPE, PDA, etc.)
  • Ability to assemble, analyze and evaluate data and to be able to make appropriate and well-reasoned recommendations and decisions.
  • Must demonstrate a high commitment to quality.
  • Must be able to manage multiple tasks and work independently.
  • Must be able to lead teams and manage schedules and budgets for small to mid-size projects.
  • Must be able to accept unexpected assignments as needed.
  • Customer focus and being a team player are a must; experience in working with global teams is a plus.

Education/Other Requirements

  • Bachelor’s degree in a Life Science, Engineering, Computer Science or another related discipline preferred.
  • Candidates must be open to travel as it can be significant depending on where the company has been contracted to perform work.
  • Commissioning Agents is an Equal Opportunity Employer.
  • Qualified candidates must be legally authorized to be employed in the United States. CAI does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
  • We welcome your interest in our organization and are pleased to accept applications if your background and interests match the work and goals of our company. However, due to the volume of inquiries we receive, we will only respond directly to your application if it matches a current opening and if your qualifications match our needs.

Indeed - 5 months ago - save job - block
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