Associate Director, Commissioning and Start-Up Engineering (BDS)

AbbVie · Durham, NC, United States

  • Junior
  • Full-time
  • Posted 2026-09-24
  • Confirmed live on 25 September 2026

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Job description

Job Description
The Associate Director, Commissioning and Start-Up is responsible for providing operational leadership for commissioning, qualification, and start-up activities supporting new manufacturing sites, facilities expansion, utilities, equipment, and related systems. This role ensures assets are delivered safely, compliantly, and on schedule in a state of readiness for GMP operations, while meeting Abbvie quality, operational, and business objectives. The Associate Director leads cross-functional teams and external partners while enabling a smooth transition from project execution to sustained operational performance.
  Key Responsibilities

• Provide leadership for commissioning, qualification, and start-up activities across facilities, utilities, equipment, and supporting systems.

• Develop program strategy and lead detailed execution of Hazard and Operability (HAZOP) Studies for all capital programs.

• Develop, align, and execute commissioning and start-up strategies, plans, schedules, protocols, and turnover packages.

• Ensure readiness of systems for GMP operations in compliance with applicable regulatory, quality, safety, and company standards.

• Partner cross-functionally with engineering, validation, manufacturing, quality, EHS, automation, project management, and third-party contractors to deliver integrated startup execution.

• Manage risks, dependencies, timelines, budgets, and issue resolution throughout the project lifecycle.

• Support and oversee site walkdown processes against as built Piping & Instrumentation Diagrams along with Equipment installations to ensure accuracy and operational readiness. 

• Lead troubleshooting and corrective action efforts during startup to support successful implementation and stable operations.

• Lead operational readiness and the successful integration of new assets into routine site operations.

• Support budgeting, resource planning, for commissioning and start-up efforts.

Qualifications
Qualifications:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical discipline required; advanced degree preferred.

• Typically, 10-12 years20+ years of relevant experience in pharmaceutical or biotech manufacturing and engineering or other highly regulated manufacturing environments.

• Broad experience in commissioning, qualification, start-up, validation, or operational readiness.

• Demonstrated experience leading cross-functional teams. Ability to manage multiple priorities, work through ambiguity, and drive execution in a matrixed organization.

• Strong track record of delivering results in a GMP-regulated environment.

• Strong project leadership, organizational, and communication skills.

• Ability to influence and drive alignment across functions and business units.
Preferred Qualifications

• Experience supporting facility expansions, new product introductions, or major capital projects.

• Experience in sterile injectables, biologics, API, or oral solid dose manufacturing.

• Experience with risk-based CQV methodology and digital turnover systems.

• Prior people leadership experience in a matrixed, global, or highly collaborative environment.
Leadership Competencies

• Strategic leadership

• Enterprise Mindset

• Cross-functional influence

• Accountability and decision-making

• Change leadership

• Operational excellence

• Compliance and quality focus
Work Environment: This role may require travel to project and manufacturing sites and extended hours during critical commissioning and start-up phases.
Key internal stakeholders for an Associate Director of Commissioning and Plant Start-Up typically include:

• Site Leadership and Site Director – overall site strategy, priorities, and operational readiness

• Engineering Leadership through Director and VP – design execution, utilities, facilities, and project delivery

• Validation / CQV Team – commissioning, qualification, and validation strategy and execution

• Quality Assurance leadership thru Director Level – cGMP compliance, documentation, and release readiness

• EHS (Environmental, Health & Safety) thru Director and VP Level – safe startup, risk controls, and compliance

• Automation / IT / Digital Systems – control systems, data integrity, MES, and infrastructure readiness

• Maintenance / Reliability (MEP) Team – asset readiness, PM strategy, spares, and maintainability

• Project Management / PMO Organization – schedule, scope, budget, and governance

• Procurement / Strategic Sourcing thru Director Level – contractor and vendor management

• HR / Talent / Learning – staffing, training, and organizational readiness

• Finance – budget tracking and capital spend governance

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible ba

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