CQV Specialist - Microbulk Tie-Ins

Fishers, Indiana Quality Engineering 14 days ago

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Summary: Seeking a CQV Specialist with expertise in microbulk tie-ins to develop, author, and execute commissioning and qualification documentation for a Bulk CO2 Gas System.

  • Requirements:

    • Bachelor's degree in Engineering, Life Sciences, or related field preferred
    • 5+ years of experience in CQV activities in a regulated environment focusing on gas systems
    • Strong expertise in document authorship, including protocol development and report writing
    • Hands-on experience with gas sampling coordination and system validation in cGMP environments
    • Comprehensive knowledge of cGMP regulations and quality management systems

  • Responsibilities:

    • Develop and execute CQV documentation for Bulk CO2 Gas System
    • Collaborate with project teams for system installation, commissioning, and validation
    • Coordinate and document gas sampling activities to validate system performance
    • Prepare detailed documentation aligning with cGMP standards
    • Identify and address technical challenges during commissioning and qualification phases


Pay Details: $32.00 to $43.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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