Job DescriptionPosition Summary: 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.
Key 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.
Qualifications- 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.
Preferred Qualifications: - 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.
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 a Director of Commissioning and Plant Start-Up typically include:
- Site Leadership and Site Director - overall site strategy, priorities, and operational readiness
- Engineering Leadership thru VP Level- design execution, utilities, facilities, and project delivery
- Validation / CQV Team - commissioning, qualification, and validation strategy and execution
- Quality Assurance leadership thru VP Level - cGMP compliance, documentation, and release readiness
- EHS (Environmental, Health & Safety) thru 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 VP 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.
