C&Q Engineer II

Commissioning & Qualification (C&Q) Engineer II

Role Title: C&Q Engineer II

Reports To: C&Q Lead / C&Q Principal, ACE Technologies

Location: Indianapolis, IN / Lebanon, IN (On-site)

Role Purpose

The C&Q Engineer II is a mid-level engineering role responsible for independently executing commissioning and qualification activities while managing defined project scope. This role builds on the foundation developed at Engineer I level by adding greater ownership of systems, direct client interaction, and leadership of small technical tasks or sub-teams. The C&Q Engineer II ensures deliverables meet regulatory and client expectations while supporting project progress and team development.

Core Responsibilities

Protocol Development & Execution

• Develop and execute C&Q protocols with minimal supervision.
• Take ownership of assigned systems or equipment within the project.
• Document test results, deviations, and resolutions with accuracy and compliance.

Technical Documentation

• Prepare validation deliverables such as risk assessments, test plans, and summary reports.
• Review and provide feedback on documentation produced by C&Q Engineer I staff.
• Ensure all documents are compliant, audit-ready, and aligned with regulatory standards.

Project Support & Coordination

• Coordinate system-level C&Q activities with vendors, contractors, and clients.
• Contribute to project schedules, resource planning, and reporting.
• Escalate issues proactively and propose solutions to maintain progress.

Compliance & Quality

• Apply risk-based verification and industry best practices (e.g., ASTM E2500, ISPE guidelines).
• Ensure execution complies with GMP, FDA, and client requirements.
• Support internal and client audits as required.

Mentorship & Team Support

• Mentor and provide guidance to C&Q Engineer I team members.
• Contribute to knowledge transfer and training within the project team.

Key Competencies

• Independent problem-solving and technical execution.
• Strong documentation and organizational skills.
• Effective communicator with clients, vendors, and teammates.
• Ability to balance multiple priorities within project timelines.
• Emerging leadership skills, including mentoring junior staff.

Qualifications

• 2–5 years of experience in commissioning, qualification, or validation (pharma, biotech, chemical, or related industries).
• Bachelor’s degree in Engineering or related technical field.
• Demonstrated ability to manage assigned systems or project scope independently.
• Familiarity with GMP, FDA, and industry guidelines (ASTM E2500, ISPE).
• Proficiency with validation and project management tools (e.g., Kneat, Smartsheet).

Position Context

• Full-time, on-site role at ACE project locations in Indianapolis and Lebanon.
• Directly interfaces with clients and vendors.
• Serves as a technical resource and mentor while progressing toward senior-level responsibilities.