Get job as soon as 2 days (HURRY UP) ENROLL NOW or Call   +1 (804)-454-3215

Job ID : 27646

Location : San Jose, CA

Company Name : Procal Technologies

Job Type : contract

Industry : Healthcare

Salary : $45 - $50  per year

No. of Positions : 5-10

Required Skills : Validation.

Benefits : None of These

Job Description :


The Validation Engineer will be responsible for completing the commissioning and qualification activities for the equipment and systems included in a new Sterility Suite at one of our clients. The Sterility Suite will be created as part of a facility upgrade project to reconfigure an existing space into a new, Grade D clean suite. The qualification will include commissioning, qualification, and validation (CQV) of the new suite and the Environmental Monitoring PQ (EMPQ) of the space. The project also includes CQV of the following equipment and systems:

· Air Handling Unit - Commissioning/IOQ/Integration with Building Automation System (BAS)

· 2 Isolators - Commissioning/IOQ/EMPQ/Vaporized Hydrogen Peroxide (VHP) PQ

· 4 Incubators - Commissioning/IOQ

· 1 Refrigerator - Commissioning/IOQ

Estimated duration of the project is 6 months for a team of 2 resources with most of the work being completed onsite at the client’s facility in Southern California.


· Generate and route for approval the Commissioning & Qualification Protocols for the equipment/system.

· Generate and route for approval the test cases required for the equipment/system.

· Support the execution, resolution of discrepancies/deviations, and approval of the test case required for the equipment.

· Support updates to equipment and system lifecycle documentation, as needed.

· Support VHP cycle development for Isolators as required.

· Generate and route for approval the CQP Reports.

· Maintain training current on relevant SOPs.

· Daily accounting of time and activities submitted to PM weekly.

Qualifications/Required Skills:

· 4-year degree in Engineering, Life Sciences, or similarly related field.

· 5 years of experience with Commissioning, Qualification, and Validation (CQV) in in the Life Sciences/FDA Regulated Industries including utilities, facilities, and equipment

· Experience interpreting and updating Life Cycle Documentation including User Requirements (URS), System Specification (SS), System Risk Assessments (SRAs), and Design Qualifications (DQ)

· Experience generating and executing Commissioning/Qualification protocols for Cleanrooms and HVAC systems, Air Handling Units (AHU), Building Management/Automation Systems.

· Experience generating and executing Environmental Monitoring PQs.

· Experience with VHP cycle development and generation and execution of VHP PQ protocols

· Experience with commissioning/qualification of thermal chambers (incubators and refrigerators) including temperature mapping, use of Kaye Validator or equivalent test instruments.

· Excellent Written and Verbal Communication Skills.

· Motivated/Self Starter Individual capable of independent work with minimal oversight.

Recommended jobs for you

  • Python Developer

    Apollose Jersey, AR

    Responsibilities :   Responsibilities: Work with a team of passionate individuals that accept open communication, empowerment, and a shared focus on customer success.

    View Job
  • Java Developer

    Apollose Austin, IN

    Responsibilities : Responsibilities: Analyze, design, and implement technical solutions fulfilling business requirements on our core on-prime services and new AWS ones. Keeping in m

    View Job
  • Data Engineer

    Apollose Ohio City, OH

    Responsibilities : Responsibilities: Build pipelines to manage audience data for personalized marketing campaigns, integrate audience data from various sources to build one view of

    View Job
  • Senior Data Analyst

    Apollose San Antonio, FL

    Responsibilities : Responsibilities: Drive the interaction with both account management and customer to develop a data driven approach to move project from concept to a scaled desig

    View Job
  • Web Designer

    Apollose Philadelphia, NY

    Responsibilities : Responsiblties: Responsible for the design, development, testing, implementation, maintenance, support and overall management of Northside Hospital Corporate webs

    View Job

Thanks For Your Feedback

We’re an equal opportunity provider.
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. is not a Consulting Company/Training Company/H1B Sponsor.

Attach A Resume First