Job DescriptionThe 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.
QualificationsQualifications: - 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 InformationApplicable 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 base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
