C&Q Engineer I - Recent Graduate

Commissioning & Qualification (C&Q) Engineer I

Role Title: C&Q Engineer I

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

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

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.

C&Q Engineers I gain foundational experience in technical documentation, protocol execution, and project coordination while contributing to high-impact projects in a client-facing environment.

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.

Qualifications

• 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.

Position Context

• Full-time, entry-level engineering role with on-site work at ACE’s Lebanon and Indianapolis project sites.
• Provides foundational training and experience in commissioning, qualification, and validation.
• Designed as a career-launching role with clear development pathways into more senior C&Q engineering and leadership positions.