Job Description

Commissioning & Qualification (C&Q) Engineer I / II

Location: Lebanon, Indiana

Employment Type: Full-Time

Company: ACE Technologies

Position Summary

ACE Technologies is seeking motivated and detail-oriented Commissioning & Qualification (C&Q) Engineers to support pharmaceutical manufacturing projects in the Lebanon, Indiana area. This position offers an opportunity to work on large-scale capital projects supporting equipment startup, commissioning, qualification, and validation activities within a GMP-regulated environment.

Candidates will be considered for either the C&Q Engineer I or C&Q Engineer II level based on education, experience, and demonstrated qualifications.

Key Responsibilities

Commissioning & Qualification Activities

• Execute commissioning and qualification protocols for process equipment, utilities, facilities, and support systems.
• Perform field testing, system walkdowns, startup support, and troubleshooting activities.
• Document test results and ensure completion of all required qualification deliverables.
• Support equipment turnover from construction through operational readiness.
• Assist with FATs (Factory Acceptance Tests) and SATs (Site Acceptance Tests) as required.

Documentation & Compliance

• Develop, review, and execute commissioning and qualification documentation.
• Ensure compliance with GMP requirements, Good Documentation Practices, and client procedures.
• Support deviation investigations, corrective actions, and change management activities.
• Maintain accurate, organized, and audit-ready project documentation.

Project Support

• Collaborate with project managers, engineering teams, contractors, vendors, and client personnel.
• Participate in project meetings and communicate progress, risks, and technical issues.
• Support project schedules and milestone achievement.
• Contribute to continuous improvement initiatives and best practices.

C&Q Engineer I

Position Overview

The C&Q Engineer I is an entry-level engineering role intended for recent graduates or engineers with limited industry experience. Individuals in this role will work under the guidance of senior engineers while developing technical knowledge of commissioning, qualification, validation, and pharmaceutical manufacturing systems.

Responsibilities

• Execute qualification protocols under supervision.
• Assist with commissioning and startup activities.
• Support data collection and documentation efforts.
• Participate in field troubleshooting and issue resolution.
• Learn GMP requirements and validation methodologies.
• Support project teams in achieving schedule and quality objectives.

Minimum Qualifications

• Bachelor's degree in Engineering, Engineering Technology, or a related technical discipline.
• 0-2 years of relevant experience.
• Strong communication and organizational skills.
• Demonstrated problem-solving ability.
• Ability to work both independently and within a team environment.
• Willingness to work in construction and manufacturing environments.

Preferred Qualifications

• Internship or co-op experience in pharmaceutical, manufacturing, automation, or engineering environments.
• Exposure to commissioning, validation, or quality systems.
• Understanding of pharmaceutical manufacturing processes.

C&Q Engineer II

Position Overview

The C&Q Engineer II is an experienced engineering role responsible for independently managing assigned systems, developing qualification documentation, and leading commissioning and qualification activities. Individuals at this level are expected to provide technical leadership within their assigned scope and serve as a primary point of contact for project execution activities.

Responsibilities

• Independently develop and execute commissioning and qualification protocols.
• Lead system walkdowns, startup activities, and troubleshooting efforts.
• Manage assigned systems from construction completion through qualification and turnover.
• Author qualification reports, investigations, and technical documentation.
• Interface directly with clients, contractors, and vendors.
• Mentor and support junior engineers.
• Lead deviation resolution and technical issue investigations.
• Drive project deliverables to completion while meeting schedule commitments.

Minimum Qualifications

• Bachelor's degree in Engineering, Engineering Technology, or a related technical discipline.
• 2-5+ years of experience in commissioning, qualification, validation, pharmaceutical manufacturing, or regulated industries.
• Strong technical writing and documentation experience.
• Ability to interpret P&IDs, process flow diagrams, equipment drawings, and technical specifications.
• Experience working within GMP-regulated environments.
• Proven ability to manage assigned deliverables with limited supervision.

Preferred Qualifications

• Direct C&Q experience supporting pharmaceutical, biotechnology, or life sciences projects.
• Experience with clean utilities, process equipment, facility systems, or automation platforms.
• Knowledge of DeltaV, Building Automation Systems (BAS), SCADA, or related control systems.
• Experience supporting facility startup and capital project execution.

Why Join ACE Technologies?

• Support some of the largest pharmaceutical manufacturing projects in the industry.
• Work alongside experienced engineering and validation professionals.
• Gain exposure to commissioning, qualification, validation, automation, and startup activities.
• Clear career growth opportunities within a rapidly growing organization.
• Competitive compensation, benefits, and professional development opportunities.

C&Q Engineer I: 0-2 Years Experience

C&Q Engineer II: 2-5+ Years Experience

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