C&Q Engineer II
Ace Technologies, LLC.
Summary
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.
Job description
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.
Requirements
- 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)
Company overview
ACE Technologies, LLC is a specialized engineering services company headquartered in Indianapolis, Indiana, that provides comprehensive system integration, commissioning, and validation solutions for the pharmaceutical and biotechnology industries. The company focuses on helping life sciences clients design, automate, and qualify manufacturing facilities of the future, combining technical precision with regulatory compliance expertise. ACE Technologies offers turnkey automation and electrical design services, flexible staffing solutions, and digital validation capabilities across pharmaceutical, biotechnology, and water treatment systems. Their team brings extensive experience in PLC, DCS, DeltaV, and other control systems, delivering projects that accelerate facility development while ensuring adherence to strict quality standards. The company serves as a critical partner for pharmaceutical manufacturers seeking to optimize production processes, enhance operational efficiency, and maintain regulatory confidence in their manufacturing operations.