Director – Commissioning and Qualification

Job Title : Director Commissioning and Qualification

Location : Indianapolis, IN

Experience : 10+ years

Employment Type : 12+ months Contract

Overview

The Director of Commissioning and Qualification (C&Q) will lead all aspects of commissioning and qualification across major capital projects within the Global Facilities Delivery Projects organization. This role is central to ensuring that systems, equipment, and processes are designed, installed, and verified to meet both regulatory and business standards in a pharmaceutical or biotech manufacturing environment.

You'll oversee the full lifecycle of C&Q-from defining strategy and processes to guiding project teams on execution-while ensuring alignment with industry standards, safety principles, and GMP compliance.

Key Responsibilities

Strategic Leadership

Develop and lead comprehensive global commissioning and qualification (C&Q) strategies for large-scale capital projects.

Ensure consistent C&Q methodologies and best practices are applied across multiple project sites and facilities.

Collaborate with engineering, quality, and operations to align C&Q strategies with broader business and compliance goals.

Process and Program Development

Establish and maintain standardized procedures and documentation to support commissioning and qualification activities.

Create and implement guidance for project-specific C&Q leaders on developing execution plans, schedules, budgets, and traceability matrices.

Drive alignment with ASTM E2500 standards and verification methodologies.

Execution Oversight

Provide technical direction and oversight to project C&Q leaders, ensuring all systems and equipment meet regulatory and quality requirements.

Monitor project performance, budgets, and timelines, proactively identifying risks and recommending mitigation strategies.

Partner with engineering and construction teams to ensure seamless integration between design, build, and qualification phases.

Safety and Compliance

Lead the development of global safety programs related to commissioning and qualification.

Train and coach project C&Q teams on executing field safety protocols and quality procedures.

Ensure all activities comply with GMP, process safety, and other relevant industry regulations.

Team and Vendor Management

Work closely with the Process Equipment Center of Excellence (COE) and other stakeholders to maintain a qualified and diverse vendor base.

Guide and mentor C&Q professionals to build internal expertise and ensure consistent execution across projects.

Assess market trends, contractor capabilities, and technological innovations to support decision-making and optimize project delivery.

Qualifications

Required

Bachelor's degree in Engineering, Life Sciences, or Project Management (or equivalent).

Minimum of 10 years of progressive experience in commissioning, qualification, and validation within the pharmaceutical or biotechnology sector.

Proven leadership in developing and implementing C&Q programs across multiple large-scale facilities.

Strong understanding of GMP principles and process safety in a regulated environment.

Exceptional communication, organizational, and leadership skills.

Preferred

Experience managing C&Q from design through to handover and operational readiness.

Solid understanding of ASTM E2500 and risk-based verification methodologies.

PMP or equivalent project management certification.

Familiarity with automation systems, process utilities, and cleanroom facility design.

Work Environment

Collaboration with multi-disciplinary project teams, including engineering, construction, operations, and quality assurance.

Role involves oversight of global capital projects and may require occasional travel to project sites.