Commissioning & Qualification Lead

About the Company

ACE Technologies is committed to delivering excellence in pharmaceutical manufacturing projects, ensuring compliance with regulatory and industry standards while fostering a culture of quality, safety, and accountability.

About the Role

The Commissioning & Qualification (C&Q) Lead is responsible for managing and executing commissioning and qualification activities for major pharmaceutical manufacturing projects. This role ensures compliance with regulatory and industry standards, supports project delivery excellence, and provides technical leadership to cross-functional teams. The C&Q Lead acts as a subject matter expert, overseeing planning, execution, and documentation to enable successful facility startup and sustained operations.

Responsibilities

C&Q Planning & Execution

• Lead all C&Q activities across assigned systems, equipment, and facilities.
• Ensure compliance with GMP, FDA, and industry standards throughout all project phases.
• Develop project-specific validation approaches consistent with client and ACE requirements.

Documentation & Compliance

• Prepare, review, and approve C&Q deliverables, including Project Validation Plans, User Requirements, IV/OV test plans, and summary reports.
• Ensure all documentation meets regulatory expectations and project standards.
• Maintain traceability and alignment of requirements, testing, and acceptance criteria.

Test Execution

• Oversee and perform Installation Verification (IV) and Operational Verification (OV) testing.
• Ensure test protocols are executed accurately and deviations are resolved appropriately.
• Validate that systems are qualified and ready for operational use.

Team Leadership & Development

• Provide technical guidance and mentorship to C&Q engineers and junior staff.
• Build capability within the project team through knowledge sharing and coaching.
• Promote ACE’s culture of quality, safety, and accountability.

Continuous Improvement

• Identify opportunities for process improvement within commissioning and qualification activities.
• Recommend and implement solutions that improve efficiency and compliance.
• Stay current with regulatory changes and industry best practices.

Stakeholder Engagement

• Collaborate with equipment vendors, contractors, and client representatives to ensure smooth project execution.
• Act as a key point of contact for C&Q scope within assigned systems.
• Escalate issues proactively and drive timely resolution with stakeholders.

Qualifications

• Minimum of 5 years of experience in commissioning and qualification within pharmaceutical, biotech, chemical, or related industries.
• Bachelor’s degree in Engineering, Life Sciences, or related field (advanced degree preferred).
• Demonstrated experience leading large-scale C&Q efforts and cross-functional project teams.
• Familiarity with GMP, FDA, EMA, and ISPE guidelines is preferred; strong working knowledge of ASTM E2500 and risk-based verification approaches.
• Proficiency in project and validation management tools (e.g., Kneat, Smartsheet, or equivalent).

Required Skills

• Strong understanding of commissioning, qualification, and validation methodologies.
• Analytical problem-solver with attention to detail and regulatory compliance.
• Effective communicator able to influence across disciplines and levels.
• Organized and adaptable, with proven ability to manage competing priorities.
• Leadership presence with capability to guide technical teams.

Preferred Skills

• Experience with advanced project management methodologies.
• Knowledge of additional regulatory frameworks and standards.

Pay range and compensation package

Full-time, on-site role based in Lebanon, IN with additional time at the Indianapolis office as needed. Salary and compensation details will be discussed during the interview process.

Equal Opportunity Statement

ACE Technologies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.