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Lead CQV Engineer

Stark Pharma Solutions Inc

  • Indianapolis, IN
  • 2 days ago

    Highlights

    We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success. We are seeking a Lead CQV Engineer with 8+ years of pharmaceutical commissioning and qualification experience, specializing in documentation across all C&Q phases.

    Numbers & Facts

    LocationIndianapolis, IN

    Description

    About the Company

    Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

    Position: Lead CQV Engineer
    Location: Indianapolis, IN
    Duration: Long Term

    Job Overview

    We are seeking a Lead CQV Engineer with 8+ years of pharmaceutical commissioning and qualification experience, specializing in documentation across all C&Q phases. The ideal candidate will have strong P&ID interpretation skills, hands-on field experience, and direct system startup experience.

    Key Responsibilities

    • Manage and review C&Q/CQV documentation across all project phases.
    • Serve as the documentation SME for commissioning and qualification activities.
    • Conduct field walkdowns and verify systems against P&IDs and engineering documents.
    • Interpret P&IDs to support system verification and startup readiness.
    • Support system startups and resolve field and documentation issues.
    • Coordinate with Engineering, Construction, Commissioning, and Validation teams.
    • Ensure documentation accuracy, completeness, traceability, and compliance.

    Required Qualifications

    • 8+ years of pharmaceutical C&Q/CQV engineering experience; 10+ years preferred.
    • Expert-level documentation knowledge across all C&Q phases.
    • Strong P&ID interpretation and practical field application experience.
    • Direct experience supporting system startups.
    • Hands-on field walkdown and system verification experience.
    • Comfortable working in a field-intensive, onsite pharmaceutical environment.
    • Strong communication, troubleshooting, and coordination skills.

    How to Apply

    Apply Now: Submit your updated resume along with your LinkedIn profile to Stark Pharma Solutions Inc. for consideration.

    Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.

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