Director, Commissioning and Start-Up Engineering

AbbVie•Durham, NC

13h•$160,500 - $305,000•Hybrid

About The Position

The Director of Commissioning and Start-Up Engineering is a senior leadership role responsible for establishing and executing commissioning, qualification, and start-up strategies for major capital projects, facility expansions, and new manufacturing operations. This role provides enterprise-level leadership to ensure assets are delivered safely, compliantly, and on schedule while meeting AbbVie quality, operational, and business objectives. The Director leads cross-functional teams and external partners through turnover, readiness, and operational handoff in highly regulated manufacturing environments.

Requirements

Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related technical discipline required; advanced degree preferred.
Typically 20+ years of relevant experience in pharmaceutical or biotech manufacturing and engineering or other highly regulated manufacturing environments.
Extensive leadership experience in commissioning, qualification, validation, and plant start-up for complex facilities or capital projects.
Demonstrated success leading large, cross-functional teams and managing multiple stakeholders in a matrixed organization.
Strong knowledge of cGMP, regulatory expectations, EHS standards, and manufacturing quality systems.
Proven ability to lead major facility or process start-up efforts from design transfer through operational readiness.
Strong project leadership, organizational, and communication skills.
Ability to influence senior leaders and drive alignment across functions and business units.

Nice To Haves

Experience in sterile injectables, biologics, API, or oral solid dose manufacturing.
Experience with risk-based CQV methodology and digital turnover systems.
Experience supporting global or multi-site capital project portfolios.
PMP, Lean, Six Sigma, or equivalent leadership certification preferred.

Responsibilities

Lead the development and execution of comprehensive commissioning and start-up strategies for major capital projects and manufacturing expansions.
Develop program strategy and lead detailed execution of Hazard and Operability (HAZOP) Studies for all capital programs.
Leads site walkdown processes against as built Piping & Instrumentation Diagrams along with Equipment installations to ensure accuracy and operational readiness.
Provide strategic direction for CQV readiness, turnover governance, and transition-to-operations planning.
Ensure commissioning and start-up activities align with AbbVie’s safety, quality, cost, and schedule expectations.
Direct cross-functional teams across Engineering, Validation, Quality, Operations, Automation, Maintenance, Supply Chain, and EHS.
Oversee readiness for utilities, process systems, cleanrooms, automation platforms, and supporting infrastructure.
Establish and maintain project governance, milestone tracking, risk management, and escalation pathways.
Drive operational readiness activities including SOP development, training, staffing readiness, maintenance planning, spare parts strategy, and documentation completion.
Manage third-party contractors, consultants, and integration partners to ensure execution quality and accountability.
Partner with site leadership and functional leaders to ensure successful transition from project delivery to stable operations.
Ensure all turnover, commissioning, and start-up activities comply with cGMP, regulatory, and EHS requirements.
Champion standardization, continuous improvement, and lessons learned across projects and sites.
Influence budget, resource planning, and strategic prioritization for commissioning and start-up efforts.
Serve as a senior escalation point for execution risks, startup issues, and readiness gaps.