Job Description

Job Description: Commissioning & Qualification (C&Q) Engineer III / Senior C&Q Engineer

Role Title: C&Q Engineer III / Senior C&Q Engineer

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

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

About the Role

ACE Technologies is seeking experienced Commissioning & Qualification (C&Q) Engineers to support pharmaceutical and biotechnology manufacturing projects. We are hiring at either the Engineer III or Senior Engineer level based on experience, technical expertise, and demonstrated leadership capabilities.

Successful candidates will lead commissioning and qualification activities, execute validation deliverables, collaborate with client teams, and ensure compliance with GMP and regulatory requirements. More experienced candidates will be expected to manage larger project scopes, provide technical leadership, and mentor junior engineers.

Key Responsibilities

Commissioning & Qualification Execution

• Lead commissioning and qualification activities for manufacturing systems, equipment, and facilities.
• Execute Installation Verification (IV), Operational Verification (OV), and related qualification activities, ensuring protocols are executed accurately and deviations are resolved appropriately.
• Support facility start-up, equipment qualification, and system turnover.
• Apply risk-based verification principles and industry best practices.

Documentation & Compliance

• Develop, review, and execute validation and qualification documentation.
• Prepare validation plans, risk assessments, protocols, deviations, and summary reports.
• Ensure all deliverables are compliant with GMP, FDA, EMA, ISPE, and ASTM E2500 requirements.
• Maintain complete traceability and audit readiness, including support for client audits and regulatory inspections.

Project Leadership & Stakeholder Engagement

• Coordinate activities across vendors, contractors, client teams, and internal stakeholders.
• Identify project risks and develop mitigation plans; escalate issues proactively and drive timely resolution.
• Support schedule management, resource planning, and project reporting.
• Serve as a primary technical contact for assigned systems or project areas.

Team Development & Continuous Improvement

• Provide technical guidance and mentorship to junior engineers.
• Share best practices and lessons learned across project teams.
• Support continuous improvement initiatives that increase quality, efficiency, and compliance.
• Stay current with regulatory changes and industry best practices.

Key Competencies

• Strong technical knowledge of commissioning, qualification, and validation methodologies.
• Analytical problem-solving with attention to detail and regulatory compliance.
• Leadership presence in client and vendor interactions.
• Effective communication across disciplines and levels.
• Ability to manage competing priorities with adaptability and ownership of project outcomes.

Qualifications

Engineer III Level

• 5-8 years of commissioning, qualification, validation, or related pharmaceutical engineering experience.
• Experience leading system-level or workstream-level C&Q activities.
• Strong understanding of GMP, FDA, EMA, ISPE, and ASTM E2500 principles.
• Ability to independently execute and coordinate qualification activities.
• Bachelor’s degree in Engineering or related technical discipline.

Senior Engineer Level

• 8+ years of commissioning, qualification, validation, or related pharmaceutical engineering experience.
• Demonstrated success leading major C&Q projects and cross-functional teams.
• Subject matter expertise in qualification strategy, risk-based verification, and regulatory compliance.
• Strong client-facing leadership and project management capabilities.
• Proven ability to mentor engineers and drive project execution.
• Bachelor’s degree in Engineering or related technical discipline; advanced degree preferred.

Preferred Qualifications

• Experience supporting pharmaceutical, biotechnology, cell & gene therapy, vaccine, or chemical manufacturing facilities.
• Experience with tools such as Kneat, Smartsheet, MS Project, or equivalent validation platforms.
• Factory Acceptance Test (FAT), SAT, startup, and commissioning experience.
• Strong communication and stakeholder management skills.

What Determines Level Placement?

Candidates will be hired as either an Engineer III or Senior Engineer based on:

• Years of relevant experience
• Scope of previous project leadership
• Technical expertise
• Client-facing responsibilities
• Mentorship and leadership experience
• Ability to independently manage large project workstreams

Position Context

• Full-time, on-site role based in Indianapolis or Lebanon, IN.
• Close coordination with project engineering, operations, and quality functions.
• Travel may be required for Factory Acceptance Testing (FAT) and vendor site support.
• Opportunity to grow toward C&Q Lead responsibilities.

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