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C&Q Engineer I - Recent Graduate

Ace Technologies, LLC.

Indianapolis, INOnsitePosted 1 day ago
Full TimeNew Grad & Entry LevelManufacturing & CMCLife Science Service & Supply
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Summary

The Commissioning & Qualification (C&Q) Engineer I is an entry-level engineering role designed for recent or soon-to-be graduates interested in pharmaceutical facility startup and validation. The role provides hands-on experience with regulated manufacturing systems, supporting the delivery of qualified equipment, utilities, and facilities that comply with industry, client, and regulatory standards.

Job description

Role Purpose

The Commissioning & Qualification (C&Q) Engineer I is an entry-level engineering role designed for recent or soon-to-be graduates interested in pharmaceutical facility startup and validation. The role provides hands-on experience with regulated manufacturing systems, supporting the delivery of qualified equipment, utilities, and facilities that comply with industry, client, and regulatory standards.

Core Responsibilities

Protocol Development & Execution

  • Support the preparation, execution, and documentation of commissioning and qualification protocols.
  • Conduct testing for process equipment, utilities, and facilities in compliance with GMP and client standards.
  • Accurately record test data, deviations, and resolution steps.

Technical Documentation

  • Assist in developing and maintaining validation deliverables such as test plans, reports, and traceability matrices.
  • Ensure documentation is clear, accurate, and audit-ready.
  • Follow established templates, procedures, and regulatory requirements.

Project Support

  • Contribute to the development and maintenance of project schedules and budgets.
  • Track progress and escalate issues to C&Q Leads for timely resolution.
  • Collaborate with vendors, contractors, and client representatives during system testing and troubleshooting.

Compliance & Quality

  • Adhere to FDA, GMP, and industry standards for commissioning and qualification.
  • Follow ACE's quality processes, ensuring all work is performed to regulatory and client expectations.
  • Demonstrate accountability for assigned deliverables.

Team Collaboration & Development

  • Work as part of a cross-functional project team under the guidance of senior engineers.
  • Learn and apply industry best practices for C&Q and validation.
  • Build skills in problem-solving, project execution, and client communication.

Key Competencies

  • Strong technical aptitude and eagerness to learn pharmaceutical manufacturing systems.
  • Excellent written and verbal communication skills, able to adapt to both technical and non-technical audiences.
  • Analytical thinker with problem-solving ability.
  • Organized and detail-oriented, with the ability to manage tasks independently.
  • Team-oriented, collaborative, and adaptable to fast-paced project environments.

Requirements

  • Bachelor's degree in Engineering (all disciplines considered) or a related technical field
  • 0–2 years of experience (internships, co-ops, or academic projects in engineering or life sciences considered a plus)
  • Ability to work independently while contributing to a team-based environment
  • Strong decision-making and problem-solving skills
  • Excellent written and verbal communication skills
  • Organized and detail-oriented
  • Team-oriented and collaborative

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.

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